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
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1994	TE:		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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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