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Last Updated: November 23, 2024

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. Ten 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
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 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:RXDosage:POWDER;SUBCUTANEOUSStrength45MG
Approval Date:May 1, 2020TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 22, 2041Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Dec 22, 2041Product Flag?Substance Flag?YDelist Request?

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

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