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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021431
Company: FOREST LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAMPRAL ACAMPROSATE CALCIUM 333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, DELAYED RELEASE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/30/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021431s015lbl.pdf
12/13/2010 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021431s013lbl.pdf
07/29/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21431lbl.pdf
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