FDA Approves Multiple Supplemental Submissions for Phentermine Hydrochloride (ANDA 088596)

The Food and Drug Administration’s Abbreviated New Drug Application (ANDA) 088596 concerns an oral tablet product marketed as PHENTERMINE HYDROCHLORIDE, containing 37.5 mg of the active ingredient per tablet. The product is recorded as discontinued. The original application (submission 1) received approval on 4 April 1984. A review document for this original submission is available (dated 13 April 1999). Since the original approval, the FDA has granted approval for numerous supplemental submissions (type SUPPL). These include labeling supplements (submission numbers 5, 9, 10, 11, 14, 15, 17) with approval dates ranging from 15 September 1989 to 3 November 1998, and manufacturing (CMC) supplements (submission numbers 2, 6, 7, 13, 18) approved between 22 May 1986 and 26 July 2000. All supplemental submissions are listed as approved (status "AP").