Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085319
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
03/14/1977 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-36 Manufacturing (CMC)-Facility

Label is not available on this site.

06/01/1999 SUPPL-34 Labeling

Label is not available on this site.

04/08/1998 SUPPL-33 Labeling

Label is not available on this site.

12/19/1997 SUPPL-32 Labeling

Label is not available on this site.

10/16/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/31/1989 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

06/27/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/19/1990 SUPPL-25 Labeling

Label is not available on this site.

05/12/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/04/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/15/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/16/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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