LABELS · 9db3c914-8c33-4b65-86d3-5dc5c775b00b

Jatenzo

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: 2025-09-30
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE JATENZO (testosterone undecanoate) is an androgen 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 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. 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. Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established. Safety and efficacy of JATENZO in males less than 18 years old have not been established [ see Use in Specific Populations ( 8.4 ) ]. JATENZO (testosterone undecanoate) 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 JATENZO in men with “age-related hypogonadism” have not been established ( 1 ) Safety and efficacy of JATENZO in males less than 18 years old have not been established ( 1 , 8.4 ).

Full extracted label fields

application numbers

NDA206089

boxed warning exact

brand names

Jatenzo

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ed7b5d41-7475-4c10-99b9-b62b3434ae60

generic names

TESTOSTERONE UNDECANOATE

9db3c914-8c33-4b65-86d3-5dc5c775b00b

indications and usage exact

1 INDICATIONS AND USAGE JATENZO (testosterone undecanoate) is an androgen 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 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. 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. Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established. Safety and efficacy of JATENZO in males less than 18 years old have not been established [ see Use in Specific Populations ( 8.4 ) ]. JATENZO (testosterone undecanoate) 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 JATENZO in men with “age-related hypogonadism” have not been established ( 1 ) Safety and efficacy of JATENZO in males less than 18 years old have not been established ( 1 , 8.4 ).

indications and usage tables exact

is original packager

true

manufacturer names

TOLMAR Inc.

matched search terms

tumors

package ndcs

69087-158-12
69087-198-12
69087-237-12
69087-237-28

product ndcs

69087-158
69087-198
69087-237

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

RECENT MAJOR CHANGES Boxed Warning, Increases in Blood Pressure Removed 03/2025 Indications and Usage (1) 03/2025 Contraindications, Men with “age related hypogonadism” (4) Removed 03/2025 Warnings and Precautions , Venous Thromboembolism (5.2) 03/2025 Warnings and Precautions, Blood Pressure Increases (5.4) 03/2025 Warnings and Precautions, Cardiovascular Risk (5.3) Removed 03/2025 Boxed Warning, Increases in Blood Pressure Removed 07/2025 Indications and Usage ( 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 ( 5.3 ) Removed 07/2025

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source batch

file

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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

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brand names

Jatenzo

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exact text: 1 INDICATIONS AND USAGE JATENZO (testosterone undecanoate) is an androgen 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 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. Hypogonadotropic hypogonadism (co
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qualifier mentions

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exact text: 1 INDICATIONS AND USAGE JATENZO (testosterone undecanoate) is an androgen 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 syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
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use intent

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Passage 2 · unclassified context

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exact text: ailure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter 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. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. The
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exact text: These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
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use intent

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Passage 3 · unclassified context

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exact text: age 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. 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. Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have
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exact text: Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
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Passage 4 · unclassified context

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exact text: ge. 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. Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established. Safety and efficacy of JATENZO in males less than 18 years old have not been estab
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Passage 5 · limitation of use

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exact text: g 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. Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established. Safety and efficacy of JATENZO in males less than 18 years old have not been established [ see Use in Specific Populations ( 8.4 ) ]. JATENZO (testosterone undecanoate) is an androgen indicated for t
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exact text: stosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established. Safety and efficacy of JATENZO in males less than 18 years old have not been established [ see Use in Specific Populations ( 8.4 ) ]. JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 )
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Passage 7 · positive indication candidate

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exact text: in men with “age-related hypogonadism” have not been established. Safety and efficacy of JATENZO in males less than 18 years old have not been established [ see Use in Specific Populations ( 8.4 ) ]. JATENZO (testosterone undecanoate) 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 JATENZO in men with “age-related hypogonadism” have not been established ( 1 ) Safety and efficacy of JATENZO in males less than 18 years old have not been
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androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absenc
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exact text: JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ).
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exact text: ATENZO (testosterone undecanoate) 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 JATENZO in men with “age-related hypogonadism” have not been established ( 1 ) Safety and efficacy of JATENZO in males less than 18 years old have not been established ( 1 , 8.4 ).
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hed ( 1 ) Safety and efficacy of JATENZO in males less than 18 years old have not been established ( 1 , 8.4 ).
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exact text: Limitations of use: Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established ( 1 ) Safety and efficacy of JATENZO in males less than 18 years old have not been established ( 1 , 8.4 ).
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Preserved source evidence · Not medical advice