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 fifteen drug master file entries for this compound. Four 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020388

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Dec 23, 1994	TE:	AP	RLD:	Yes

Expired US 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;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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