LABELS · 2bcfa6a9-635f-6bc9-ec72-839cca27541e

Tlando

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-02-25
Captured: 2026-09-09T23:37:42.544548+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration ( 2.2 )]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established [see Use in Specific Populations ( 8.5 )] . TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ). Safety and efficacy of TLANDO in men with “age-related hypogonadism” have not been established ( 1 ).

Full extracted label fields

application numbers

NDA208088

boxed warning exact

brand names

Tlando

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b0b92e9-6d3c-a0e5-e1c7-342999f72580

generic names

TESTOSTERONE UNDECANOATE

2bcfa6a9-635f-6bc9-ec72-839cca27541e

indications and usage exact

1 INDICATIONS AND USAGE TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration ( 2.2 )]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established [see Use in Specific Populations ( 8.5 )] . TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ). Safety and efficacy of TLANDO in men with “age-related hypogonadism” have not been established ( 1 ).

indications and usage tables exact

is original packager

true

manufacturer names

Verity Pharmaceuticals Inc.

matched search terms

tumors

package ndcs

74676-0112-2

product ndcs

74676-0112

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

RECENT MAJOR CHANGES SECTION Boxed Warnings, Blood Pressure Increases Removed 07/2025 Indications and Usage, Limitations of Use ( 1 ) 07/2025 Contraindications, Men with “age related hypogonadism” (4) Removed 07/2025 Warnings and Precautions, Venous Thromboembolism ( 5.2 ) 07/2025 Warnings and Precautions, Blood Pressure Increases ( 5.4 ) 07/2025 Warnings and Precautions, Cardiovascular Risk (5.4) Removed 07/2025

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2599054
2599060

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00100.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA208088

brand names

Tlando

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 639
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration ( 2
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 0

current approval status

not_reconciled

duplicate text group

dup-9a175f663aa3239d1e91

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-98346be3a6a505f11457

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

end: 43
end exclusive: true
exact text: is indicated
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 31

qualifier mentions

context exact
TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absenc
kind
age
polarity
not_inferred
span
end
89
end exclusive
true
exact text
adult
label id
2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start
84
context exact
ndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
kind
biomarker
polarity
not_inferred
span
end
438
end exclusive
true
exact text
metals
label id
2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start
432

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 439
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 2 · unclassified context

application numbers

NDA208088

brand names

Tlando

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 845
end exclusive: true
exact text: lure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration ( 2.2 )]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. The
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 240

current approval status

not_reconciled

duplicate text group

dup-f719485724bad1b78d3e

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-b0a0e389189714762d2f

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 645
end exclusive: true
exact text: These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration ( 2.2 )].
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 440

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · unclassified context

application numbers

NDA208088

brand names

Tlando

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1041
end exclusive: true
exact text: men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration ( 2.2 )]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in mal
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 446

current approval status

not_reconciled

duplicate text group

dup-a7038398d228473b78a8

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-c2f79a132703daa45269

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 841
end exclusive: true
exact text: Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 646

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

application numbers

NDA208088

brand names

Tlando

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1185
end exclusive: true
exact text: )]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Safety and efficacy of TLANDO in men with “age-r
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 642

current approval status

not_reconciled

duplicate text group

dup-3a39cd0cf7e904aca79f

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-2ce45374bb336937ad5c

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 985
end exclusive: true
exact text: These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Administration ( 2.2 )].
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 842

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · limitation of use

application numbers

NDA208088

brand names

Tlando

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1336
end exclusive: true
exact text: -hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established [see Use in Specific Populations ( 8.5 )] . TLANDO is an
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 786

current approval status

not_reconciled

duplicate text group

dup-41bd1fd74cc7235c5a35

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-b472cf8a4a3271e40dcb

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

Source null

qualifier mentions

context exact
ons of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populati
kind
age
polarity
not_inferred
span
end
1062
end exclusive
true
exact text
18 years
label id
2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start
1054

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 1136
end exclusive: true
exact text: Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] .
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 986

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 6 · limitation of use

application numbers

NDA208088

brand names

Tlando

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1523
end exclusive: true
exact text: w range [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established [see Use in Specific Populations ( 8.5 )] . TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 937

current approval status

not_reconciled

duplicate text group

dup-c3116add7005ea216d30

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-7536ea221a7ae010bc0b

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 1323
end exclusive: true
exact text: Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established [see Use in Specific Populations ( 8.5 )] .
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 1137

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 7 · positive indication candidate

application numbers

NDA208088

brand names

Tlando

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1696
end exclusive: true
exact text: s ( 8.4 )] . Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established [see Use in Specific Populations ( 8.5 )] . TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ). Safety and efficacy of TLANDO in men with “age-related hypogonadism” have not been es
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 1124

current approval status

not_reconciled

duplicate text group

dup-a23ef4b17033b77c3233

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-4d35b5f1f348580de8bc

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

end: 1355
end exclusive: true
exact text: is an androgen indicated
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 1331

qualifier mentions

context exact
androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absenc
kind
age
polarity
not_inferred
span
end
1401
end exclusive
true
exact text
adult
label id
2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start
1396

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 1496
end exclusive: true
exact text: TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ).
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 1324

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 8 · limitation of use

application numbers

NDA208088

brand names

Tlando

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1712
end exclusive: true
exact text: fic Populations ( 8.5 )] . TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ). Safety and efficacy of TLANDO in men with “age-related hypogonadism” have not been established ( 1 ).
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 1297

current approval status

not_reconciled

duplicate text group

dup-9f84242fc703f935ac54

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-b1e28f43f55d6c68d880

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

Source null

qualifier mentions

context exact
ons of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ).
kind
age
polarity
not_inferred
span
end
1573
end exclusive
true
exact text
18 years
label id
2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start
1565

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 1610
end exclusive: true
exact text: Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ).
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 1497

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 9 · limitation of use

application numbers

NDA208088

brand names

Tlando

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1712
end exclusive: true
exact text: conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ). Safety and efficacy of TLANDO in men with “age-related hypogonadism” have not been established ( 1 ).
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 1411

current approval status

not_reconciled

duplicate text group

dup-310b9a5278b5562205a0

extraction review status

automated_candidate_pending_source_review

generic names

TESTOSTERONE UNDECANOATE

ind-span-bbc9f85ecc1c17dcd6d9

label id

2bcfa6a9-635f-6bc9-ec72-839cca27541e

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 1712
end exclusive: true
exact text: Safety and efficacy of TLANDO in men with “age-related hypogonadism” have not been established ( 1 ).
label id: 2bcfa6a9-635f-6bc9-ec72-839cca27541e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 1e1b547fe9dcf988bddc0a04e004dd7660b43f577aba2febcd33423d402d715d
start: 1611

source url

https://api.fda.gov/drug/label.json?search=id%3A%222bcfa6a9-635f-6bc9-ec72-839cca27541e%22

spl effective date

2026-02-25

spl set id

4b0b92e9-6d3c-a0e5-e1c7-342999f72580

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice