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FDA ANDA · ANDA200142
ACAMPROSATE CALCIUM
acamprosate calcium enteric-coated
Sponsor: MYLAN
APPLICATION
ANDA200142
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-11
LATEST ACTION
2014-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
ACAMPROSATE CALCIUMPrescription
ACAMPROSATE CALCIUM 333MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2014-03-11UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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