Application 021379

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	22.5MG/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
N021379-001	ELIGARD KIT	LEUPROLIDE ACETATE	22.5MG	POWDER / SUBCUTANEOUS		RLD, RS	2002-07-24

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
N021379-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27
N021379-001	11931559	2041-12-22		Drug substance	2024-04-15
N021379-001	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	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021379-001	ELIGARD	22.5MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021379-001	ELIGARD	22.5MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021379-001	ELIGARD	22.5MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021379-001	ELIGARD	22.5MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-07-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021379-001	ELIGARD KIT	22.5MG	POWDER / SUBCUTANEOUS	RLD, RS	2002-07-24	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 79 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	N021379-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021379-001	12397120	2041-12-22	U-4001		2025-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021379-001	12397120	2041-12-22	U-4001		2025-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021379-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021379-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021379-001	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	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021379-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021379-001	11931559	2041-12-22		Drug substance	2024-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021379-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021379-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021379-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021379-001	6626870	2020-03-27		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021379-001	8840916	2020-11-13		Drug product	2017-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021379-001	9539333	2020-11-13	U-621	Drug substance, Drug product	2017-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021379-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021379-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021379-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021379-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`87673890dc5c…`

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): 021379 application number: NDA021379
Eligard	LEUPROLIDE ACETATE	TOLMAR Inc.	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021379 application number: NDA021379
ELIGARD	LEUPROLIDE ACETATE	TOLMAR Inc.	b78d1919-9dee-44fa-90f9-e0a26d32481d	2019-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021379 application number: NDA021379 ndc (product): 62935-223

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
62935-222	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-223	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85888	SUPPL	2026-05-12
85853	SUPPL	2026-05-08
81370	SUPPL	2025-02-25
81345	SUPPL	2025-02-25
81014	SUPPL	2025-02-06
80964	SUPPL	2025-02-06
78529	SUPPL	2024-05-22
78528	SUPPL	2024-05-22
77294	SUPPL	2024-01-25
77286	SUPPL	2024-01-24
74860	SUPPL	2023-07-21
74859	SUPPL	2023-07-21
74848	SUPPL	2023-07-21
74849	SUPPL	2023-07-20
57736	SUPPL	2019-02-21
57699	SUPPL	2019-02-19
15347	SUPPL	2016-03-03
27644	SUPPL	2016-03-02
15346	SUPPL	2014-10-15
5231	SUPPL	2014-10-14
36801	SUPPL	2013-03-01
27643	SUPPL	2013-03-01
23652	ORIG	2011-12-20
36800	SUPPL	2011-04-11
27642	SUPPL	2011-04-11
15345	SUPPL	2011-01-20
5230	SUPPL	2011-01-20
5229	SUPPL	2010-10-13
15344	SUPPL	2010-10-12
42131	SUPPL	2008-07-31
27641	SUPPL	2007-11-19
15343	SUPPL	2007-11-13
5228	SUPPL	2004-06-03
42130	ORIG	2002-07-24
15342	ORIG	2002-07-24
5227	ORIG	2002-07-24