Application 021731

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	45MG/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
N021731-001	ELIGARD KIT	LEUPROLIDE ACETATE	45MG	POWDER / SUBCUTANEOUS		RLD, RS	2004-12-14

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
N021731-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27
N021731-001	11931559	2041-12-22		Drug substance	2024-04-15
N021731-001	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	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021731-001	ELIGARD	45MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021731-001	ELIGARD	45MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021731-001	ELIGARD	45MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021731-001	ELIGARD	45MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021731-001	ELIGARD KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2004-12-14	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 85 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	N021731-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021731-001	12397120	2041-12-22	U-4001		2025-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021731-001	12397120	2041-12-22	U-4001		2025-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021731-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021731-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021731-001	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	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021731-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021731-001	11931559	2041-12-22		Drug substance	2024-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021731-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021731-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021731-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021731-001	6626870	2020-03-27		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021731-001	8840916	2020-11-13		Drug product	2017-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021731-001	9539333	2020-11-13	U-621	Drug substance, Drug product	2017-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021731-001	9914802	2020-11-13	U-1666	Drug substance, Drug product	2018-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021731-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021731-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021731-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`782e0a99824c…`

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): 021731 application number: NDA021731
Eligard	LEUPROLIDE ACETATE	TOLMAR Inc.	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021731 application number: NDA021731
ELIGARD	LEUPROLIDE ACETATE	TOLMAR Inc.	b78d1919-9dee-44fa-90f9-e0a26d32481d	2019-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021731 application number: NDA021731 ndc (product): 62935-453

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
62935-452	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-453	ELIGARD	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85890	SUPPL	2026-05-12
85855	SUPPL	2026-05-08
81372	SUPPL	2025-02-25
81347	SUPPL	2025-02-25
81016	SUPPL	2025-02-06
80966	SUPPL	2025-02-06
78533	SUPPL	2024-05-22
78532	SUPPL	2024-05-22
77296	SUPPL	2024-01-25
77288	SUPPL	2024-01-24
74864	SUPPL	2023-07-21
74863	SUPPL	2023-07-21
74857	SUPPL	2023-07-21
74855	SUPPL	2023-07-21
72745	SUPPL	2022-11-29
57734	SUPPL	2019-02-21
57697	SUPPL	2019-02-19
37552	SUPPL	2016-03-03
6079	SUPPL	2016-03-02
37551	SUPPL	2014-10-15
6078	SUPPL	2014-10-14
37550	SUPPL	2013-03-01
28490	SUPPL	2013-03-01
23674	ORIG	2011-12-20
37549	SUPPL	2011-04-11
28489	SUPPL	2011-04-11
16276	SUPPL	2011-01-20
6077	SUPPL	2011-01-20
28488	SUPPL	2010-10-13
37548	SUPPL	2010-10-12
6076	SUPPL	2007-11-19
16275	SUPPL	2007-11-13
28487	SUPPL	2006-10-05
21796	ORIG	2006-09-27