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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070910
Company: ACTAVIS ELIZABETH
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
01/02/1987 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
11/02/2001 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/2001 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

01/18/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/19/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/14/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/11/1991 SUPPL-21 Labeling

Label is not available on this site.

06/14/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/14/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/14/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/01/1989 SUPPL-14 Bioequivalence

Label is not available on this site.

10/05/1988 SUPPL-11 Labeling

Label is not available on this site.

08/23/1989 SUPPL-10 Labeling

Label is not available on this site.

04/08/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/08/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/16/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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