LABELS · 5b7465cd-3367-44ee-a11d-d021d6400a23

PANRETIN

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: 2025-11-25
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE 1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.

Full extracted label fields

application numbers

NDA020886

boxed warning exact

brand names

PANRETIN

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49c16717-7d86-4257-80c9-baa1417e5555

generic names

ALITRETINOIN

5b7465cd-3367-44ee-a11d-d021d6400a23

indications and usage exact

1 INDICATIONS AND USAGE 1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.

indications and usage tables exact

is original packager

true

manufacturer names

Advanz Pharma (US) Corp.

matched search terms

sarcoma

package ndcs

59212-601-22

product ndcs

59212-601

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

TOPICAL

rxcuis

213502
313847

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 300
total: 830

terms

https://open.fda.gov/terms/

sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b7465cd-3367-44ee-a11d-d021d6400a23%22

spl effective date

2025-11-25

spl effective time

20251125

spl set id

49c16717-7d86-4257-80c9-baa1417e5555

spl version

substance names

ALITRETINOIN

uniis

1UA8E65KDZ

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA020886
payload
all indexed label documents
Appl No
020886
Application Docs Date
1999-02-02 00:00:00
Application Docs ID
13670
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
020886
Application Docs Date
2025-11-18 00:00:00
Application Docs ID
84194
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020886s009lbl.pdf
Submission No
9
Submission Type
SUPPL
all submission records
Appl No
020886
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
1999-02-02 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
020886
Review Priority
Submission Class Code ID
4
Submission No
1
Submission Status
AP
Submission Status Date
1999-07-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020886
Review Priority
Submission Class Code ID
4
Submission No
2
Submission Status
AP
Submission Status Date
2000-11-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020886
Review Priority
Submission Class Code ID
4
Submission No
6
Submission Status
AP
Submission Status Date
2013-11-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2025-11-17 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA020886
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020886
has approved submission record
true
latest approved submission date
2025-11-17
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
020886
Application Docs Date
2025-11-18 00:00:00
Application Docs ID
84194
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020886s009lbl.pdf
Submission No
9
Submission Type
SUPPL
official application record
Appl No
020886
Appl Public Notes
Appl Type
NDA
Sponsor Name
ADVANZ PHARMA
openfda application present
true
products
Active Ingredient
ALITRETINOIN
Appl No
020886
Drug Name
PANRETIN
Form
GEL;TOPICAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 0.1% BASE
marketing status
Prescription

Source passages and status connections

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

Passage 1 · unclassified context

application numbers

NDA020886

brand names

PANRETIN

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 223
end exclusive: true
exact text: 1 INDICATIONS AND USAGE 1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when sys
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 0

current approval status

not_reconciled

duplicate text group

dup-06e00bbfff74571ff66d

extraction review status

automated_candidate_pending_source_review

generic names

ALITRETINOIN

ind-span-d231f05e238eea44dfbc

label id

5b7465cd-3367-44ee-a11d-d021d6400a23

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 23
end exclusive: true
exact text: 1 INDICATIONS AND USAGE
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b7465cd-3367-44ee-a11d-d021d6400a23%22

spl effective date

2025-11-25

spl set id

49c16717-7d86-4257-80c9-baa1417e5555

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 2 · positive indication candidate

application numbers

NDA020886

brand names

PANRETIN

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 364
end exclusive: true
exact text: 1 INDICATIONS AND USAGE 1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 0

current approval status

not_reconciled

duplicate text group

dup-d57eeb2d465256a6c2b7

extraction review status

automated_candidate_pending_source_review

generic names

ALITRETINOIN

ind-span-b609fad4ee555dc4e2b3

label id

5b7465cd-3367-44ee-a11d-d021d6400a23

positive predicate support span

end: 70
end exclusive: true
exact text: is indicated
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 58

qualifier mentions

context exact
is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS).
kind
age
polarity
not_inferred
span
end
123
end exclusive
true
exact text
adults
label id
5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start
117

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 164
end exclusive: true
exact text: 1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS).
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 24

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b7465cd-3367-44ee-a11d-d021d6400a23%22

spl effective date

2025-11-25

spl set id

49c16717-7d86-4257-80c9-baa1417e5555

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

tumor_directed_candidate

Passage 3 · limitation of use

application numbers

NDA020886

brand names

PANRETIN

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 636
end exclusive: true
exact text: 1 INDICATIONS AND USAGE 1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use : PANRETIN GEL is not indicated when systemic
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 0

current approval status

not_reconciled

duplicate text group

dup-780be76632f4b4888f25

extraction review status

automated_candidate_pending_source_review

generic names

ALITRETINOIN

ind-span-4543a7684555c58fab45

label id

5b7465cd-3367-44ee-a11d-d021d6400a23

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 436
end exclusive: true
exact text: Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] .
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 165

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b7465cd-3367-44ee-a11d-d021d6400a23%22

spl effective date

2025-11-25

spl set id

49c16717-7d86-4257-80c9-baa1417e5555

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 4 · positive indication candidate

application numbers

NDA020886

brand names

PANRETIN

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 679
end exclusive: true
exact text: therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 237

current approval status

not_reconciled

duplicate text group

dup-59eed9963cfef904f4ff

extraction review status

automated_candidate_pending_source_review

generic names

ALITRETINOIN

ind-span-75ca26121f34b7a16f0d

label id

5b7465cd-3367-44ee-a11d-d021d6400a23

positive predicate support span

end: 473
end exclusive: true
exact text: is a retinoid indicated
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 450

qualifier mentions

context exact
indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS).
kind
age
polarity
not_inferred
span
end
530
end exclusive
true
exact text
adults
label id
5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit
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source array index
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source field
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source text sha256
d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start
524
context exact
PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s
kind
biomarker
polarity
not_inferred
span
end
498
end exclusive
true
exact text
retinoid indicated for the topical treatmen
label id
5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start
455

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 571
end exclusive: true
exact text: PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS).
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 437

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b7465cd-3367-44ee-a11d-d021d6400a23%22

spl effective date

2025-11-25

spl set id

49c16717-7d86-4257-80c9-baa1417e5555

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

tumor_directed_candidate

Passage 5 · limitation of use

application numbers

NDA020886

brand names

PANRETIN

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 679
end exclusive: true
exact text: ptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 372

current approval status

not_reconciled

duplicate text group

dup-a23db76f32b0be3fc390

extraction review status

automated_candidate_pending_source_review

generic names

ALITRETINOIN

ind-span-0d145818d91938464ba7

label id

5b7465cd-3367-44ee-a11d-d021d6400a23

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 679
end exclusive: true
exact text: Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.
label id: 5b7465cd-3367-44ee-a11d-d021d6400a23
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d3a5f654e63334b2f1b857df1668e01079c1c283aefc6784eb07da02153c4822
start: 572

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b7465cd-3367-44ee-a11d-d021d6400a23%22

spl effective date

2025-11-25

spl set id

49c16717-7d86-4257-80c9-baa1417e5555

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