Application 021343

Type: NDA
Sponsor: TOLMAR THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELIGARD	LEUPROLIDE ACETATE	INJECTABLE;SUBCUTANEOUS	7.5MG/VIAL	Yes	Yes

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
N021343-001	ELIGARD KIT	LEUPROLIDE ACETATE	7.5MG	POWDER / SUBCUTANEOUS		RLD, RS	2002-01-23

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27
N021343-001	11931559	2041-12-22		Drug substance	2024-04-15
N021343-001	12397120	2041-12-22	U-4001		2025-09-22

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021343-001	ELIGARD	7.5MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021343-001	ELIGARD	7.5MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021343-001	ELIGARD	7.5MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021343-001	ELIGARD	7.5MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021343-001	ELIGARD KIT	7.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-01-23	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021343-001	12397120	2041-12-22	U-4001		2025-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021343-001	12397120	2041-12-22	U-4001		2025-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021343-001	11931559	2041-12-22		Drug substance	2024-04-15	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N021343-001	6626870	2020-03-27		Drug product		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021343-001	6626870	2020-03-27		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021343-001	6626870	2020-03-27		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021343-001	6626870	2020-03-27		Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021343-001	6626870	2020-03-27		Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021343-001	6626870	2020-03-27		Drug product		`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021343-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`a72a2bbeb626…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vabrinty	LEUPROLIDE ACETATE	URONOVA PHARMACEUTICALS, INC.	008776cc-83f1-4f8c-819b-6471425da15f	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021343 application number: NDA021343
Eligard	LEUPROLIDE ACETATE	TOLMAR Inc.	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021343 application number: NDA021343
ELIGARD	LEUPROLIDE ACETATE	TOLMAR Inc.	b78d1919-9dee-44fa-90f9-e0a26d32481d	2019-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021343 application number: NDA021343 ndc (product): 62935-753

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62935-752	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-753	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85887	SUPPL	2026-05-12
85852	SUPPL	2026-05-08
81369	SUPPL	2025-02-25
81344	SUPPL	2025-02-25
81013	SUPPL	2025-02-06
80963	SUPPL	2025-02-06
78527	SUPPL	2024-05-22
78526	SUPPL	2024-05-22
77293	SUPPL	2024-01-25
77285	SUPPL	2024-01-24
74858	SUPPL	2023-07-21
74856	SUPPL	2023-07-21
74847	SUPPL	2023-07-21
74846	SUPPL	2023-07-21
57733	SUPPL	2019-02-21
57696	SUPPL	2019-02-19
15225	SUPPL	2016-03-03
27529	SUPPL	2016-03-02
44988	SUPPL	2016-02-29
36699	SUPPL	2014-10-15
5094	SUPPL	2014-10-14
15224	SUPPL	2013-03-01
5093	SUPPL	2013-03-01
23647	ORIG	2011-12-20
36698	SUPPL	2011-04-11
5092	SUPPL	2011-04-11
27528	SUPPL	2011-01-20
15223	SUPPL	2011-01-20
27527	SUPPL	2010-10-13
36697	SUPPL	2010-10-12
5091	SUPPL	2007-11-19
36696	SUPPL	2007-11-13
27526	SUPPL	2004-01-14
5090	SUPPL	2003-07-08
5089	SUPPL	2002-04-01
36695	ORIG	2002-01-23
27525	ORIG	2002-01-23
21610	ORIG	2002-01-23