Application 213150

Type: NDA
Sponsor: TOLMAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENSOLVI	LEUPROLIDE ACETATE	INJECTABLE;INJECTION	45MG	Yes	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
N213150-001	FENSOLVI KIT	LEUPROLIDE ACETATE	45MG	POWDER / SUBCUTANEOUS		RLD, RS	2020-05-01

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
N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27
N213150-001	11931559	2041-12-22		Drug substance	2024-04-15
N213150-001	12397120	2041-12-22	U-3611		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.

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	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 61 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	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213150-001	12397120	2041-12-22	U-3611		2025-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213150-001	12397120	2041-12-22	U-3611		2025-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213150-001	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	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213150-001	9539333	2020-11-13		Drug substance, Drug product	2020-08-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213150-001	9914802	2020-11-13	U-2940	Drug substance, Drug product	2020-08-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`8869cabd3fbd…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213150-001	I-829	2023-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213150-001	I-829	2023-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213150-001	I-829	2023-05-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213150-001	I-829	2023-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213150-001	I-829	2023-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213150-001	I-829	2023-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213150-001	I-829	2023-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213150-001	I-829	2023-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213150-001	I-829	2023-05-01	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N213150-001	I-829	2023-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213150-001	I-829	2023-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213150-001	I-829	2023-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213150-001	I-829	2023-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213150-001	I-829	2023-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213150-001	I-829	2023-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213150-001	I-829	2023-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213150-001	I-829	2023-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213150-001	I-829	2023-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213150-001	I-829	2023-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213150-001	I-829	2023-05-01	`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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fensolvi	LEUPROLIDE ACETATE	TOLMAR Inc.	2c311700-edf4-4f2a-a468-9875489a6cc7	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213150 application number: NDA213150
Fensolvi	LEUPROLIDE ACETATE	TOLMAR Inc.	dfb6e01c-f138-471d-bf5b-2be38247e3f0	2022-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213150 application number: NDA213150 ndc (product): 62935-153

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62935-153	Fensolvi	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-153	Fensolvi	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-153	Fensolvi	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-153	Fensolvi	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-153	Fensolvi	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-153	Fensolvi	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current
62935-153	Fensolvi	Leuprolide Acetate	TOLMAR PHARMACEUTICALS INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83471	SUPPL	2025-09-25
83470	SUPPL	2025-09-25
83428	SUPPL	2025-09-24
82168	SUPPL	2025-05-08
79945	SUPPL	2024-10-21
79914	SUPPL	2024-10-18
72730	SUPPL	2022-11-28
72729	SUPPL	2022-11-28
70823	SUPPL	2022-04-27
70822	SUPPL	2022-04-27
70812	SUPPL	2022-04-26
65951	ORIG	2021-01-21
62822	ORIG	2020-05-05
62816	ORIG	2020-05-04
62815	ORIG	2020-05-04