Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084399
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENDIMETRAZINE TARTRATE 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
05/28/1981 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
10/18/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/27/1992 SUPPL-18 Labeling

Label is not available on this site.

09/30/1991 SUPPL-17 Labeling

Label is not available on this site.

09/27/1990 SUPPL-16 Labeling

Label is not available on this site.

06/10/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/16/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/16/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/11/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/27/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/27/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/16/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/16/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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