Last Updated: May 3, 2026

Details for New Drug Application (NDA): 218984

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NDA 218984 describes ACAMPROSATE CALCIUM, which is a drug marketed by Appco, Barr Labs Div Teva, Bionpharma, Glenmark Pharms Ltd, Mylan, and Zydus Pharms, and is included in six NDAs. It is available from eight 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. Eight suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.

Summary for 218984

Tradename:	ACAMPROSATE CALCIUM
Applicant:	Appco
Ingredient:	acamprosate calcium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	Mar 16, 2026	TE:	AB	RLD:	No

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