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Generated: December 15, 2018

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Details for New Drug Application (NDA): 200142

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NDA 200142 describes ACAMPROSATE CALCIUM, which is a drug marketed by Barr Labs Div Teva, Glenmark Generics, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in four NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.
Summary for 200142
Tradename:ACAMPROSATE CALCIUM
Applicant:Mylan Pharms Inc
Ingredient:acamprosate calcium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200142
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 200142 ANDA Mylan Pharmaceuticals Inc. 0378-6333 0378-6333-80 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)
ACAMPROSATE CALCIUM acamprosate calcium TABLET, DELAYED RELEASE;ORAL 200142 ANDA Mylan Institutional Inc. 51079-241 51079-241-06 50 BLISTER PACK in 1 CARTON (51079-241-06) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (51079-241-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength333MG
Approval Date:Mar 11, 2014TE:ABRLD:No

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