Application 019010

Type: NDA
Sponsor: ABBVIE ENDOCRINE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUPRON	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N019010-001	LUPRON	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS		RLD	1985-04-09

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	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019010-001	LUPRON	14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	1985-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019010-001	LUPRON	1MG/0.2ML	INJECTABLE / INJECTION	RLD	1985-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019010-001	LUPRON	1MG/0.2ML	INJECTABLE / INJECTION	RLD	1985-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019010-001	LUPRON	1MG/0.2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1985-04-09	`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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	Endo USA, Inc.	290b0716-2fd5-43a1-8d3c-4857c1b2eefa	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
Fensolvi	LEUPROLIDE ACETATE	TOLMAR Inc.	dfb6e01c-f138-471d-bf5b-2be38247e3f0	2022-04-28	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
ELIGARD	LEUPROLIDE ACETATE	TOLMAR Inc.	b78d1919-9dee-44fa-90f9-e0a26d32481d	2019-04-29	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85882	SUPPL	2026-05-12
85845	SUPPL	2026-05-08
83625	SUPPL	2025-10-02
83621	SUPPL	2025-10-01
83589	SUPPL	2025-09-30
83475	SUPPL	2025-09-25
57626	ORIG	2019-02-15
57141	SUPPL	2019-01-09
56830	SUPPL	2018-12-20
53721	SUPPL	2018-04-18
48984	SUPPL	2017-07-14
48954	SUPPL	2017-07-12
48497	SUPPL	2017-05-23
48467	SUPPL	2017-05-19
48466	SUPPL	2017-05-19
11413	SUPPL	2014-07-11
1200	SUPPL	2014-07-11
23546	ORIG	2011-12-20
1199	SUPPL	2011-03-24
11412	SUPPL	2011-03-21
33686	SUPPL	2011-01-20
16168	SUPPL	2011-01-20
11411	SUPPL	2010-05-07
1198	SUPPL	2010-05-04
1197	SUPPL	2007-09-25
40859	SUPPL	2007-07-09
40858	SUPPL	2007-07-09
20196	SUPPL	2007-07-09
20195	SUPPL	2007-07-09
1196	SUPPL	2005-10-20
1195	SUPPL	2004-10-22
1194	SUPPL	2003-12-02