Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 081249
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
07/16/1992 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
08/29/2017 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/21/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/23/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/11/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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