Details for New Drug Application (NDA): 213150

✉ Email this page to a colleague

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 three 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. Fifteen 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:	3

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:	⤷ Get Started Free	Patent Expiration:	Dec 22, 2041	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Dec 22, 2041	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Dec 22, 2041	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PEDIATRIC PATIENTS WITH CENTRAL PRECOCIOUS PUBERTY

Expired US Patents for NDA 213150

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	⤷ Get Started Free	⤷ Get Started Free
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	⤷ Get Started Free	⤷ Get Started Free
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.