Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074119
Company: TEVA
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
12/19/1994 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
08/13/2002 SUPPL-23 Labeling

Label is not available on this site.

08/13/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2002 SUPPL-21 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/07/2000 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

10/22/1999 SUPPL-19 Labeling

Label is not available on this site.

03/09/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/01/1997 SUPPL-17 Labeling

Label is not available on this site.

01/29/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/30/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/06/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/06/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/20/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/12/1996 SUPPL-3 Labeling

Label is not available on this site.

11/17/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/20/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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