Application 021288

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 11.25MG 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
N021288-001	TRELSTAR	TRIPTORELIN PAMOATE	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR		RLD, RS	2001-06-29

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	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021288-001	TRELSTAR	EQ 11.25MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2001-06-29	`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): 021288 application number: NDA021288 ndc (product): 74676-5904

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
0023-5904	Trelstar	triptorelin pamoate	Allergan, Inc.	NDA	Current
0023-5904	Trelstar	triptorelin pamoate	Allergan, Inc.	NDA	Current
74676-5904	Trelstar	triptorelin pamoate	Verity Pharmaceuticals Inc.	NDA	Current
74676-5904	Trelstar	triptorelin pamoate	Verity Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83478	SUPPL	2025-09-25
83433	SUPPL	2025-09-25
81571	SUPPL	2025-03-14
81551	SUPPL	2025-03-13
78143	SUPPL	2024-04-15
78130	SUPPL	2024-04-15
76641	SUPPL	2023-11-21
76634	SUPPL	2023-11-20
73690	SUPPL	2023-03-06
73686	SUPPL	2023-03-06
56909	SUPPL	2018-12-21
56783	SUPPL	2018-12-18
27395	SUPPL	2014-07-15
14902	SUPPL	2014-07-15
36593	SUPPL	2013-03-15
4934	SUPPL	2013-03-15
44114	ORIG	2011-12-20
27394	SUPPL	2011-05-24
36592	SUPPL	2011-05-23
14901	SUPPL	2011-01-20
4933	SUPPL	2011-01-20
4932	SUPPL	2008-04-16
27393	SUPPL	2005-10-25
21577	ORIG	2002-01-07
36591	ORIG	2001-06-29
4931	ORIG	2001-06-29