Details for New Drug Application (NDA): 213150

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NDA 213150 describes FENSOLVI KIT, which is a drug marketed by Tolmar and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the FENSOLVI KIT profile page.

The generic ingredient in FENSOLVI KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for 213150

Tradename:	FENSOLVI KIT
Applicant:	Tolmar
Ingredient:	leuprolide acetate
Patents:	2

Pharmacology for NDA: 213150

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 213150

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Suppliers and Packaging for NDA: 213150

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150	NDA	TOLMAR Inc.	62935-153	62935-153-50	1 KIT in 1 CARTON (62935-153-50) * .375 mL in 1 SYRINGE (62935-154-50) * .375 mL in 1 SYRINGE (62935-155-40)
FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150	NDA	TOLMAR Inc.	62935-163	62935-163-60	1 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;SUBCUTANEOUS			Strength	45MG
Approval Date:	May 1, 2020	TE:		RLD:	Yes
Patent:	11,771,841	Patent Expiration:	Dec 22, 2041	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	11,931,559	Patent Expiration:	Dec 22, 2041	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 213150

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	8,470,359	⤷ Subscribe
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	9,539,333	⤷ Subscribe
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	9,914,802	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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