Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085320
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-46 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1991 SUPPL-41 Labeling

Label is not available on this site.

01/05/1990 SUPPL-40 Labeling

Label is not available on this site.

10/24/1988 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/27/1988 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/18/1984 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/24/1988 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/09/1983 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/24/1984 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

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