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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 200143

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NDA 200143 describes ACAMPROSATE CALCIUM, which is a drug marketed by Barr Labs Div Teva, Glenmark Pharms Ltd, Mylan, and Zydus Pharms, and is included in four NDAs. It is available from six suppliers. Additional details are available on the ACAMPROSATE CALCIUM profile page.

The generic ingredient in ACAMPROSATE CALCIUM is acamprosate calcium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.

Summary for 200143

Tradename:	ACAMPROSATE CALCIUM
Applicant:	Barr Labs Div Teva
Ingredient:	acamprosate calcium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	Nov 18, 2013	TE:		RLD:	No

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