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Last Updated: November 6, 2025

Details for New Drug Application (NDA): 205995

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NDA 205995 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 seven 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. Seven suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.

Summary for 205995

Tradename:	ACAMPROSATE CALCIUM
Applicant:	Zydus Pharms
Ingredient:	acamprosate calcium
Patents:	0

Suppliers and Packaging for NDA: 205995

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	205995	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-569	68382-569-01	100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01)
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	205995	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-569	68382-569-05	500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	May 26, 2017	TE:	AB	RLD:	No

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