Application 206089

Type: NDA
Sponsor: CLARUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JATENZO	TESTOSTERONE UNDECANOATE	CAPSULE;ORAL	158MG	Yes	No
002	JATENZO	TESTOSTERONE UNDECANOATE	CAPSULE;ORAL	198MG	Yes	No
003	JATENZO	TESTOSTERONE UNDECANOATE	CAPSULE;ORAL	237MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N206089-001	JATENZO	TESTOSTERONE UNDECANOATE	158MG	CAPSULE / ORAL	RLD	2019-03-27
N206089-002	JATENZO	TESTOSTERONE UNDECANOATE	198MG	CAPSULE / ORAL	RLD	2019-03-27
N206089-003	JATENZO	TESTOSTERONE UNDECANOATE	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206089-001	11179402	2026-04-14		Drug substance, Drug product	2021-12-21
N206089-001	11331325	2027-01-06	U-2506		2022-06-02
N206089-001	8241664	2029-03-29	U-2506	Drug product	2019-04-08
N206089-001	10543219	2030-04-12	U-2506		2020-02-18
N206089-001	10617696	2030-04-12		Drug substance, Drug product	2020-05-05
N206089-001	11179403	2030-04-12	U-2506		2021-12-21
N206089-001	11426416	2030-04-12	U-3420		2022-09-12
N206089-001	8778916	2030-04-12		Drug product	2019-04-08
N206089-001	8492369	2030-12-20	U-2506	Drug product	2019-04-08
N206089-001	11564933	2039-04-12	U-1103		2023-02-10
N206089-001	12605391	2039-04-12	U-1103		2026-04-24
N206089-002	11179402	2026-04-14		Drug substance, Drug product	2021-12-21
N206089-002	11331325	2027-01-06	U-2506		2022-06-02
N206089-002	8241664	2029-03-29	U-2506	Drug product	2019-04-08
N206089-002	10543219	2030-04-12	U-2506		2020-02-18
N206089-002	10617696	2030-04-12		Drug substance, Drug product	2020-05-05
N206089-002	11179403	2030-04-12	U-2506		2021-12-21
N206089-002	11426416	2030-04-12	U-3420		2022-09-12
N206089-002	8778916	2030-04-12		Drug product	2019-04-08
N206089-002	8492369	2030-12-20	U-2506	Drug product	2019-04-08
N206089-002	11564933	2039-04-12	U-1103		2023-02-10
N206089-002	12605391	2039-04-12	U-1103		2026-04-24
N206089-003	11179402	2026-04-14		Drug substance, Drug product	2021-12-21
N206089-003	11331325	2027-01-06	U-2506		2022-06-02
N206089-003	8241664	2029-03-29	U-2506	Drug product	2019-04-08
N206089-003	10543219	2030-04-12	U-2506		2020-02-18
N206089-003	10617696	2030-04-12		Drug substance, Drug product	2020-05-05
N206089-003	11179403	2030-04-12	U-2506		2021-12-21
N206089-003	11426416	2030-04-12	U-3420		2022-09-12
N206089-003	8778916	2030-04-12		Drug product	2019-04-08
N206089-003	8492369	2030-12-20	U-2506	Drug product	2019-04-08
N206089-003	11564933	2039-04-12	U-1103		2023-02-10
N206089-003	12605391	2039-04-12	U-1103		2026-04-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,020 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206089-001	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	11331325	2027-01-06	U-2506		2022-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	10543219	2030-04-12	U-2506		2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	11179403	2030-04-12	U-2506		2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	11426416	2030-04-12	U-3420		2022-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	8778916	2030-04-12		Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	11564933	2039-04-12	U-1103		2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11331325	2027-01-06	U-2506		2022-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	10543219	2030-04-12	U-2506		2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11179403	2030-04-12	U-2506		2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11426416	2030-04-12	U-3420		2022-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	8778916	2030-04-12		Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11564933	2039-04-12	U-1103		2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11331325	2027-01-06	U-2506		2022-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	10543219	2030-04-12	U-2506		2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11179403	2030-04-12	U-2506		2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11426416	2030-04-12	U-3420		2022-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	8778916	2030-04-12		Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11564933	2039-04-12	U-1103		2023-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11331325	2027-01-06	U-2506		2022-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	10543219	2030-04-12	U-2506		2020-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11179403	2030-04-12	U-2506		2021-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11426416	2030-04-12	U-3420		2022-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	8778916	2030-04-12		Drug product	2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11564933	2039-04-12	U-1103		2023-02-10	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206089-001	NP	2022-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206089-002	NP	2022-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206089-003	NP	2022-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206089-001	NP	2022-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206089-002	NP	2022-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206089-003	NP	2022-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206089-001	NP	2022-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206089-002	NP	2022-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206089-003	NP	2022-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206089-001	NP	2022-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206089-002	NP	2022-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206089-003	NP	2022-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206089-001	NP	2022-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206089-002	NP	2022-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206089-003	NP	2022-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206089-001	NP	2022-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206089-002	NP	2022-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206089-003	NP	2022-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206089-001	NP	2022-03-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206089-002	NP	2022-03-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206089-003	NP	2022-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206089-001	NP	2022-03-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206089-002	NP	2022-03-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206089-003	NP	2022-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206089-001	NP	2022-03-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206089-002	NP	2022-03-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206089-003	NP	2022-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206089-001	NP	2022-03-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206089-002	NP	2022-03-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206089-003	NP	2022-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206089-001	NP	2022-03-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206089-002	NP	2022-03-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206089-003	NP	2022-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206089-001	NP	2022-03-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206089-002	NP	2022-03-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206089-003	NP	2022-03-27	`b00525d2431f…`
2023-01-26 05:58 UTC	2023-01	N206089-001	NP	2022-03-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N206089-002	NP	2022-03-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N206089-003	NP	2022-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206089-001	NP	2022-03-27	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jatenzo	TESTOSTERONE UNDECANOATE	TOLMAR Inc.	ed7b5d41-7475-4c10-99b9-b62b3434ae60	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206089 application number: NDA206089 ndc (product): 69087-198 ndc (product): 69087-237 ndc (product): 69087-158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69087-158	Jatenzo	testosterone undecanoate	Clarus Therapeutics, Inc.	NDA	Current
69087-158	Jatenzo	testosterone undecanoate	TOLMAR Inc.	NDA	Current
69087-158	Jatenzo	testosterone undecanoate	Clarus Therapeutics, Inc.	NDA	Current
69087-198	Jatenzo	testosterone undecanoate	Clarus Therapeutics, Inc.	NDA	Current
69087-198	Jatenzo	testosterone undecanoate	TOLMAR Inc.	NDA	Current
69087-198	Jatenzo	testosterone undecanoate	Clarus Therapeutics, Inc.	NDA	Current
69087-237	Jatenzo	testosterone undecanoate	Clarus Therapeutics, Inc.	NDA	Current
69087-237	Jatenzo	testosterone undecanoate	TOLMAR Inc.	NDA	Current
69087-237	Jatenzo	testosterone undecanoate	Clarus Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83353	SUPPL	2025-09-15
83352	SUPPL	2025-09-15
83351	SUPPL	2025-09-15
82874	SUPPL	2025-07-15
82843	SUPPL	2025-07-14
61042	ORIG	2019-11-25
58130	ORIG	2019-03-28
58097	ORIG	2019-03-27