Last Updated: November 8, 2026

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, Bionpharma, Glenmark Pharms Ltd, Mylan, Somerset Theraps Llc, and Zydus Pharms, and is included in six NDAs. It is available from eleven suppliers. Additional details are available on the ACAMPROSATE CALCIUM profile page.

The generic ingredient in ACAMPROSATE CALCIUM is acamprosate calcium. There is one drug master file entry for this compound. Eleven 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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