Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089025
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOXYPHENE COMPOUND 65 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE 389MG;32.4MG;65MG CAPSULE;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
03/29/1985 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
11/14/2002 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/2001 SUPPL-41 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/20/2001 SUPPL-40 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/07/2000 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

08/26/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/06/1998 SUPPL-36 Labeling

Label is not available on this site.

06/02/1997 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/19/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-32 Labeling

Label is not available on this site.

01/25/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/30/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/15/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/30/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/11/1990 SUPPL-10 Bioequivalence

Label is not available on this site.

11/03/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-6 Labeling

Label is not available on this site.

02/08/1989 SUPPL-5 Labeling

Label is not available on this site.

04/17/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/17/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/17/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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