Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040283
Company: OXFORD PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE 325MG;200MG;16MG 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
12/29/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40283ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-283_Carisoprodol%20Aspirin%20Codeine%20Phosphate.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2017 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/25/2008 SUPPL-5 Labeling

Label is not available on this site.

04/30/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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