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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. It is available from one supplier. Additional details are available on the NAVELBINE profile page.

The generic ingredient in NAVELBINE is vinorelbine tartrate. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.

Summary for NDA: 020388

Tradename:
NAVELBINE
Applicant:
Pierre Fabre
Ingredient:
vinorelbine tartrate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020388

Ingredient-typeVinca Alkaloids

Suppliers and Packaging for NDA: 020388

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAVELBINE
vinorelbine tartrate
INJECTABLE;INJECTION 020388 NDA Pierre Fabre Pharmaceuticals, Inc. 64370-532 64370-532-01 1 VIAL, SINGLE-USE in 1 CARTON (64370-532-01) > 1 mL in 1 VIAL, SINGLE-USE
NAVELBINE
vinorelbine tartrate
INJECTABLE;INJECTION 020388 NDA Pierre Fabre Pharmaceuticals, Inc. 64370-532 64370-532-02 1 VIAL, SINGLE-USE in 1 CARTON (64370-532-02) > 5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Dec 23, 1994TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020388

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pierre Fabre
NAVELBINE
vinorelbine tartrate
INJECTABLE;INJECTION020388-001Dec 23, 19944,307,100*PED► subscribe
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