Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087433
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG 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
07/22/1981 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/14/1988 SUPPL-17 Labeling

Label is not available on this site.

09/19/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/19/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/07/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/18/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/18/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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