Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085964
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG 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
07/18/1978 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
02/01/1991 SUPPL-45 Labeling

Label is not available on this site.

08/01/1989 SUPPL-44 Labeling

Label is not available on this site.

04/21/1989 SUPPL-43 Labeling

Label is not available on this site.

04/21/1989 SUPPL-42 Labeling

Label is not available on this site.

01/13/1988 SUPPL-40 Labeling

Label is not available on this site.

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