Application 075721

Type: ANDA
Sponsor: GENZYME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	1MG/0.2ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075721-001	LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS			2001-11-29

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075721-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	2001-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075721-001	LEUPROLIDE ACETATE	1MG/0.2ML	INJECTABLE / INJECTION	2001-11-29	`cb3db0bc1861…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leuprolide acetate	LEUPROLIDE ACETATE	Amneal Pharmaceuticals LLC	4838c674-044e-46b2-81e7-c691b99d8fa5	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: leuprolide acetate generic name: LEUPROLIDE ACETATE
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	Zydus Pharmaceuticals USA Inc.	35634415-000f-47db-9bd7-9e16eef3f02e	2026-05-25	Warnings, Adverse reactions	Name fallback brand name: LEUPROLIDE ACETATE generic name: LEUPROLIDE ACETATE
Leuprolide Acetate	LEUPROLIDE ACETATE	Sandoz Inc	8bd72c1e-2751-4498-a346-bc5e3acbba0b	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Leuprolide Acetate generic name: LEUPROLIDE ACETATE
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	Eugia US LLC	49a1d0c1-304c-46f2-a780-bd940ae1ced0	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: LEUPROLIDE ACETATE generic name: LEUPROLIDE ACETATE
Vabrinty	LEUPROLIDE ACETATE	URONOVA PHARMACEUTICALS, INC.	008776cc-83f1-4f8c-819b-6471425da15f	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
Eligard	LEUPROLIDE ACETATE	TOLMAR Inc.	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
leuprolide acetate	LEUPROLIDE ACETATE	Sun Pharmaceutical Industries, Inc.	a3b01473-30c7-4945-bd60-2484221aaaad	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: leuprolide acetate generic name: LEUPROLIDE ACETATE
Leuprolide Acetate	LEUPROLIDE ACETATE	Meitheal Pharmaceuticals Inc	d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Leuprolide Acetate generic name: LEUPROLIDE ACETATE
leuprolide acetate	LEUPROLIDE ACETATE	UBI Pharma Inc.	cd46628f-055f-4da9-8c38-fa69af34eb4d	2026-03-29	Warnings, Adverse reactions	Name fallback brand name: leuprolide acetate generic name: LEUPROLIDE ACETATE
Lupron Depot	LEUPROLIDE ACETATE	AbbVie Inc.	cbc8f94e-7330-4465-05ad-16d64493a5dd	2026-03-15	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	Zydus Lifesciences Limited	4bae0e2a-dd36-4987-85ee-36a52e642ec7	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: LEUPROLIDE ACETATE generic name: LEUPROLIDE ACETATE
leuprolide acetate	LEUPROLIDE ACETATE	PAI Holdings, LLC dba PAI Pharma	19be0b7f-e68a-4547-9e49-b51b12821907	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: leuprolide acetate generic name: LEUPROLIDE ACETATE
Leuprolide Acetate	LEUPROLIDE ACETATE	VGYAAN Pharmaceuticals LLC	bec9077a-3f04-4887-856d-dde2de24584d	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Leuprolide Acetate generic name: LEUPROLIDE ACETATE
Lupron Depot-PED	LEUPROLIDE ACETATE	AbbVie Inc.	e99f47d2-da10-3127-ecb3-e5d942ae6e81	2025-11-14	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
Fensolvi	LEUPROLIDE ACETATE	TOLMAR Inc.	2c311700-edf4-4f2a-a468-9875489a6cc7	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
Lupron Depot	LEUPROLIDE ACETATE	AbbVie Inc.	00c486b0-bd7b-4898-834d-8c656e5e73cb	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
Lupron Depot	LEUPROLIDE ACETATE	AbbVie Inc.	60aad237-e1da-4705-cbbb-b3ca79e89ad8	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
Leuprolide Acetate	LEUPROLIDE ACETATE	NorthStar RxLLC	0cf31b40-816b-d055-e063-6294a90af5d0	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Leuprolide Acetate generic name: LEUPROLIDE ACETATE
LUTRATE DEPOT	LEUPROLIDE ACETATE	Avyxa Pharma, LLC	3a6d1373-17d9-4289-b62f-d299ffe55831	2025-06-03	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE
LEUPROLIDE ACETATE DEPOT	LEUPROLIDE ACETATE	CIPLA USA INC.	1563a30b-66e0-445d-ba3e-1ccd5218133f	2024-08-27	Warnings, Adverse reactions	Name fallback generic name: LEUPROLIDE ACETATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8774	ORIG	2003-04-14