Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086366
Company: ALLIED PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;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
03/27/1979 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
03/12/1999 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/16/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/09/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/09/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/09/1996 SUPPL-26 Labeling

Label is not available on this site.

09/09/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/15/1995 SUPPL-24 Labeling

Label is not available on this site.

09/28/1994 SUPPL-23 Labeling

Label is not available on this site.

12/16/1993 SUPPL-22 Labeling

Label is not available on this site.

10/03/1990 SUPPL-21 Labeling

Label is not available on this site.

02/13/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-18 Labeling

Label is not available on this site.

07/13/1989 SUPPL-16 Labeling

Label is not available on this site.

05/13/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/13/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/08/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/08/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/10/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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