Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085917
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG 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
08/12/1980 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-30 Labeling

Label is not available on this site.

09/19/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/19/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/16/1983 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/17/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/08/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/17/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/17/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/12/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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