Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087918
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG 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
12/22/1983 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-20 Manufacturing (CMC)-Facility

Label is not available on this site.

06/01/1999 SUPPL-18 Labeling

Label is not available on this site.

11/03/1998 SUPPL-17 Labeling

Label is not available on this site.

08/19/1998 SUPPL-16 Labeling

Label is not available on this site.

04/08/1998 SUPPL-15 Labeling

Label is not available on this site.

12/19/1997 SUPPL-14 Labeling

Label is not available on this site.

10/16/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/27/1990 SUPPL-11 Labeling

Label is not available on this site.

02/06/1990 SUPPL-10 Labeling

Label is not available on this site.

03/15/1989 SUPPL-9 Labeling

Label is not available on this site.

05/31/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/27/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/27/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/27/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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