Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088576
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 18.75MG CAPSULE;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
05/23/1984 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-16 Manufacturing (CMC)-Facility

Label is not available on this site.

11/03/1998 SUPPL-14 Labeling

Label is not available on this site.

08/19/1998 SUPPL-13 Labeling

Label is not available on this site.

04/08/1998 SUPPL-12 Labeling

Label is not available on this site.

12/19/1997 SUPPL-11 Labeling

Label is not available on this site.

10/16/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/16/1990 SUPPL-7 Labeling

Label is not available on this site.

05/02/1989 SUPPL-6 Labeling

Label is not available on this site.

06/27/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/27/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/09/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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