Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070116
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650MG;100MG 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
10/01/1985 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-22 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

04/03/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/06/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/03/1989 SUPPL-16 Labeling

Label is not available on this site.

03/24/1989 SUPPL-15 Labeling

Label is not available on this site.

09/08/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/22/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/10/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/10/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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