Application 020708

Type: NDA
Sponsor: ABBVIE ENDOCRINE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUPRON DEPOT	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	11.25MG/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
N020708-001	LUPRON DEPOT	LEUPROLIDE ACETATE	11.25MG	INJECTABLE / INJECTION		RLD, RS	1997-03-07

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	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`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
Lupron Depot	LEUPROLIDE ACETATE	AbbVie Inc.	60aad237-e1da-4705-cbbb-b3ca79e89ad8	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020708 application number: NDA020708 ndc (product): 0074-3663

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
0074-3663	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3663	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3663	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3663	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83334	SUPPL	2025-09-11
83333	SUPPL	2025-09-11
83330	SUPPL	2025-09-11
83329	SUPPL	2025-09-11
62431	SUPPL	2020-04-03
62416	SUPPL	2020-04-02
53771	SUPPL	2018-04-23
53743	SUPPL	2018-04-19
13257	SUPPL	2013-11-05
3153	SUPPL	2013-10-31
3151	SUPPL	2012-04-02
35184	SUPPL	2012-03-28
25588	SUPPL	2012-01-25
35186	SUPPL	2012-01-23
44066	ORIG	2011-12-20
35185	SUPPL	2011-06-16
3152	SUPPL	2011-06-16
3150	SUPPL	2010-11-02
35183	SUPPL	2010-10-29
25587	SUPPL	2009-06-08
35182	SUPPL	2009-06-04
3149	SUPPL	2007-11-08
41598	SUPPL	2007-07-09
41597	SUPPL	2007-07-09
41596	SUPPL	2007-07-09
25586	SUPPL	2005-10-20
3148	SUPPL	2005-10-20
3147	SUPPL	2004-01-22
25585	SUPPL	2004-01-14
20864	ORIG	2003-08-08
20866	SUPPL	2001-11-14
13256	SUPPL	2001-09-21
3146	SUPPL	2001-09-21
20865	SUPPL	2001-08-06
41595	SUPPL	1999-06-22
3145	SUPPL	1999-02-11
25584	SUPPL	1998-04-09