Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087805
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE 37.5MG 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
12/06/1982 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/87805ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2000 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

10/19/1999 SUPPL-20 Labeling

Label is not available on this site.

11/03/1998 SUPPL-19 Labeling

Label is not available on this site.

08/19/1998 SUPPL-18 Labeling

Label is not available on this site.

04/08/1998 SUPPL-17 Labeling

Label is not available on this site.

12/19/1997 SUPPL-16 Labeling

Label is not available on this site.

06/30/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/04/1990 SUPPL-12 Labeling

Label is not available on this site.

05/02/1989 SUPPL-11 Labeling

Label is not available on this site.

05/31/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/27/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/27/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/22/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/22/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/10/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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