Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040397
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARISOPRODOL CARISOPRODOL 350MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/21/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40397ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/14/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/19/2009 SUPPL-5 Labeling

Label is not available on this site.

01/29/2009 SUPPL-2 Labeling

Label is not available on this site.

01/25/2007 SUPPL-1 Labeling

Label is not available on this site.

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