Application 022437

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRELSTAR	TRIPTORELIN PAMOATE	INJECTABLE;INTRAMUSCULAR	EQ 22.5MG BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022437-001	TRELSTAR	TRIPTORELIN PAMOATE	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR		RLD, RS	2010-03-10

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022437-001	10166181	2029-06-30		Drug product	2019-01-25

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022437-001	TRELSTAR	EQ 22.5MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2010-03-10	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022437-001	10166181	2029-02-10	Drug product	2019-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022437-001	10166181	2029-02-10	Drug product	2019-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022437-001	10166181	2029-02-10	Drug product	2019-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022437-001	10166181	2029-02-10	Drug product	2019-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022437-001	10166181	2029-06-30	Drug product	2019-01-25	`f41ea6bd6efb…`

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
Trelstar	TRIPTORELIN PAMOATE	Verity Pharmaceuticals Inc.	b1b84d62-a369-a4b7-5c41-dd1f553a18f3	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022437 application number: NDA022437 ndc (product): 74676-5906

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-5906	Trelstar	triptorelin pamoate	Allergan, Inc.	NDA	Current
0023-5906	Trelstar	triptorelin pamoate	Allergan, Inc.	NDA	Current
74676-5906	Trelstar	triptorelin pamoate	Verity Pharmaceuticals Inc.	NDA	Current
74676-5906	Trelstar	triptorelin pamoate	Verity Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83476	SUPPL	2025-09-25
83434	SUPPL	2025-09-25
81572	SUPPL	2025-03-14
81552	SUPPL	2025-03-13
78144	SUPPL	2024-04-15
78131	SUPPL	2024-04-15
76642	SUPPL	2023-11-21
76635	SUPPL	2023-11-20
73691	SUPPL	2023-03-06
73687	SUPPL	2023-03-06
56910	SUPPL	2018-12-21
56784	SUPPL	2018-12-18
17593	SUPPL	2014-07-15
7403	SUPPL	2014-07-15
29732	SUPPL	2013-03-15
17592	SUPPL	2013-03-15
44185	ORIG	2011-12-20
29731	SUPPL	2011-05-24
17591	SUPPL	2011-05-23
24310	ORIG	2011-02-17
38715	SUPPL	2011-01-20
29730	SUPPL	2011-01-20
42528	ORIG	2010-11-10
7402	ORIG	2010-03-18
38714	ORIG	2010-03-17