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Last Updated: December 7, 2021

DrugPatentWatch Database Preview

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 is one patent 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. Five 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:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 213150
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 PHARMACEUTICALS 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength45MG
Approval Date:May 1, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:May 1, 2023
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY (CPP)
Patent:⤷  Try it FreePatent Expiration:Oct 15, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY

Expired US Patents for NDA 213150

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar FENSOLVI KIT leuprolide acetate POWDER;SUBCUTANEOUS 213150-001 May 1, 2020 ⤷  Try it Free ⤷  Try it Free
Tolmar FENSOLVI KIT leuprolide acetate POWDER;SUBCUTANEOUS 213150-001 May 1, 2020 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Johnson and Johnson
Mallinckrodt
Dow
Moodys

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