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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 219904

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NDA 219904 describes ACAMPROSATE CALCIUM, which is a drug marketed by Barr Labs Div Teva, Bionpharma, Glenmark Pharms Ltd, Mylan, and Zydus Pharms, and is included in five 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 219904

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

Suppliers and Packaging for NDA: 219904

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	219904	ANDA	Bionpharma Inc.,	69452-353	69452-353-25	180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	Sep 18, 2025	TE:	AB	RLD:	No

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