Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086013
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STATOBEX PHENDIMETRAZINE TARTRATE 35MG 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
12/16/1977 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
01/25/1996 SUPPL-32 Manufacturing (CMC)

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.

03/02/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 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.

01/26/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/22/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 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.

05/25/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 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.

12/30/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/22/1991 SUPPL-9 Labeling

Label is not available on this site.

12/19/1988 SUPPL-8 Labeling

Label is not available on this site.

08/22/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/22/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/15/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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