Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085512
Company: ABC HOLDING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENAZINE-35 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
05/06/1977 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
12/13/1989 SUPPL-19 Labeling

Label is not available on this site.

06/27/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/18/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/29/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/09/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/11/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/09/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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