Application 020011

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LEUPROLIDE ACETATE	INJECTABLE;INJECTION	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	LUPRON DEPOT	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	3.75MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020011-001	LUPRON DEPOT	LEUPROLIDE ACETATE	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1990-10-22
N020011-002	LUPRON DEPOT	LEUPROLIDE ACETATE	3.75MG	INJECTABLE / INJECTION		RLD, RS	1995-10-26

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 3 · 86 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	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020011-001	LUPRON DEPOT	3.75MG/VIAL	INJECTABLE / INJECTION	RLD	1990-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020011-001	LUPRON DEPOT	3.75MG/VIAL	INJECTABLE / INJECTION	RLD	1990-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020011-001	LUPRON DEPOT	3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1990-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020011-002	LUPRON DEPOT	3.75MG	INJECTABLE / INJECTION	RLD, RS	1995-10-26	`74a2ff9319b5…`

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.	00c486b0-bd7b-4898-834d-8c656e5e73cb	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020011 application number: NDA020011 ndc (product): 0074-3641

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-3641	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3641	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3641	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3641	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3641	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current
0074-3641	Lupron Depot	leuprolide acetate	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83338	SUPPL	2025-09-11
83337	SUPPL	2025-09-11
83325	SUPPL	2025-09-11
83323	SUPPL	2025-09-11
73346	SUPPL	2023-01-31
73338	SUPPL	2023-01-30
66296	SUPPL	2021-02-18
66220	SUPPL	2021-02-16
12138	SUPPL	2013-11-05
19939	SUPPL	2013-10-31
19937	SUPPL	2012-04-02
34182	SUPPL	2012-03-28
19938	SUPPL	2012-01-25
12137	SUPPL	2012-01-23
44041	ORIG	2011-12-20
12136	SUPPL	2011-06-16
1909	SUPPL	2011-06-16
19936	SUPPL	2010-11-02
34181	SUPPL	2010-10-29
1908	SUPPL	2009-06-08
12135	SUPPL	2009-06-04
19935	SUPPL	2007-11-08
1907	SUPPL	2005-10-20
1906	SUPPL	2005-10-20
1905	SUPPL	2004-01-22
19934	SUPPL	2004-01-14
41119	SUPPL	2001-11-14
12134	SUPPL	2001-09-21
1904	SUPPL	2001-09-21
20447	SUPPL	2001-08-06
19933	SUPPL	1998-04-09