Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070146
Company: IVAX SUB TEVA PHARMS
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
08/02/1985 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
07/29/2002 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-33 Manufacturing (CMC)-Facility

Label is not available on this site.

01/17/2001 SUPPL-32 Labeling

Label is not available on this site.

01/17/2001 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/15/2000 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-28 Manufacturing (CMC)-Facility

Label is not available on this site.

02/15/2000 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/15/2000 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/17/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/12/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/12/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/13/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/21/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/30/1992 SUPPL-17 Labeling

Label is not available on this site.

07/13/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/13/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/04/1989 SUPPL-14 Labeling

Label is not available on this site.

05/16/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/16/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/16/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/02/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/03/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/04/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/04/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/04/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/07/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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