Details for New Drug Application (NDA): 213150
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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 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213150
Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
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: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 45MG | ||||
Approval Date: | May 1, 2020 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 22, 2041 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 22, 2041 | Product Flag? | Substance Flag? | Y | Delist 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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