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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 020388


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NDA 020388 describes NAVELBINE, which is a drug marketed by Pierre Fabre and is included in one NDA. Additional details are available on the NAVELBINE profile page.

The generic ingredient in NAVELBINE is vinorelbine tartrate. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.
Summary for 020388
Tradename:NAVELBINE
Applicant:Pierre Fabre
Ingredient:vinorelbine tartrate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 23, 1994TE:RLD:Yes

Expired US Patents for NDA 020388

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pierre Fabre NAVELBINE vinorelbine tartrate INJECTABLE;INJECTION 020388-001 Dec 23, 1994 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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