Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089673
Company: ANDA REPOSITORY
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
02/10/1988 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-25 Labeling-Package Insert

Label is not available on this site.

05/26/2017 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

05/26/2017 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

08/02/2013 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

06/28/2011 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

09/12/2007 SUPPL-18 Labeling

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/29/1996 SUPPL-5 Labeling

Label is not available on this site.

06/22/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/28/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/11/1992 SUPPL-1 Labeling

Label is not available on this site.

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