Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085321
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAM-METRAZINE 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
01/18/1977 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
10/06/2000 SUPPL-59 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1991 SUPPL-54 Labeling

Label is not available on this site.

12/13/1989 SUPPL-53 Labeling

Label is not available on this site.

10/24/1988 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/27/1988 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

06/07/1984 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

04/18/1984 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

04/18/1984 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

10/24/1988 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/09/1983 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

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