Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070115
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 325MG;50MG 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
06/12/1985 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
12/01/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/07/1990 SUPPL-19 Bioequivalence

Label is not available on this site.

05/01/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/12/1989 SUPPL-17 Labeling

Label is not available on this site.

02/28/1989 SUPPL-16 Labeling

Label is not available on this site.

03/27/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/21/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/11/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/11/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/30/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/30/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/18/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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