Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083923
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 8MG 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
07/01/1976 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-47 Manufacturing (CMC)-Facility

Label is not available on this site.

06/01/1999 SUPPL-45 Labeling

Label is not available on this site.

04/08/1998 SUPPL-44 Labeling

Label is not available on this site.

12/19/1997 SUPPL-43 Labeling

Label is not available on this site.

10/16/1992 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/05/1990 SUPPL-39 Labeling

Label is not available on this site.

05/31/1989 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/15/1989 SUPPL-37 Labeling

Label is not available on this site.

06/27/1988 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/11/1983 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/11/1983 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/01/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

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