Application 020715

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 3.75MG 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
N020715-001	TRELSTAR	TRIPTORELIN PAMOATE	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR		RLD, RS	2000-06-15

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	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020715-001	TRELSTAR	EQ 3.75MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR	RLD, RS	2000-06-15	`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): 020715 application number: NDA020715 ndc (product): 74676-5902

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
0023-5902	Trelstar	triptorelin pamoate	Allergan, Inc.	NDA	Current
0023-5902	Trelstar	triptorelin pamoate	Allergan, Inc.	NDA	Current
74676-5902	Trelstar	triptorelin pamoate	Verity Pharmaceuticals Inc.	NDA	Current
74676-5902	Trelstar	triptorelin pamoate	Verity Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83477	SUPPL	2025-09-25
83432	SUPPL	2025-09-25
81570	SUPPL	2025-03-14
81550	SUPPL	2025-03-13
78142	SUPPL	2024-04-15
78129	SUPPL	2024-04-15
76639	SUPPL	2023-11-21
76633	SUPPL	2023-11-20
73689	SUPPL	2023-03-06
73685	SUPPL	2023-03-06
56908	SUPPL	2018-12-21
56782	SUPPL	2018-12-18
25621	SUPPL	2014-07-15
13279	SUPPL	2014-07-15
25620	SUPPL	2013-03-15
13278	SUPPL	2013-03-15
23595	ORIG	2011-12-20
25619	SUPPL	2011-05-24
35210	SUPPL	2011-05-23
35209	SUPPL	2011-01-20
3184	SUPPL	2011-01-20
3183	SUPPL	2008-04-16
25618	SUPPL	2005-10-25
20873	ORIG	2002-07-31
25617	SUPPL	2002-01-15
3182	SUPPL	2002-01-15
35208	ORIG	2000-06-15
25616	ORIG	2000-06-15