Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017352
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FASTIN PHENTERMINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No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
08/14/1973 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/16/1998 SUPPL-19 Labeling

Label is not available on this site.

01/16/1998 SUPPL-18 Labeling

Label is not available on this site.

10/10/1997 SUPPL-17 Labeling

Label is not available on this site.

04/24/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/31/1984 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/31/1981 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/31/1981 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/17/1981 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/26/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1980 SUPPL-6 Labeling

Label is not available on this site.

10/11/1978 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/02/1977 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1975 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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