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ACAMPROSATE CALCIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2014-03-11

Drug application

FDA Application #
ANDA200142
Application type
Abbreviated New Drug Application (Generic)
Brand name
ACAMPROSATE CALCIUM
Generic name
ACAMPROSATE CALCIUM ENTERIC-COATED
Active ingredients
ACAMPROSATE CALCIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
MYLAN
Manufacturer
Mylan Pharmaceuticals Inc.
First approval
2014-03-11

Source

Authoritative
Drugs@FDA application overview
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