Manages exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight…. NDA 18074, held by Acertis Pharms. Phendimetrazine Tartrate.
As of Nov 14, 2026, NDA 18074 (Phendimetrazine Tartrate), held by Acertis Pharms, was first approved by FDA on Apr 16, 1979, with 28 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Phendimetrazine tartrate extended-release capsules are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of greater than or equal to 30 kg/m 2 or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phendimetrazine Tartrate105MG · capsule, extended release;oral | Phendimetrazine Tartrate | RxReference drug |
| Nov 13, 2020 | Supplement 37Manufacturing · Standard review | Approved | |
| Mar 22, 2019 | Supplement 36Labeling · Standard review | Approved | |
| Feb 10, 2012 | Supplement 34Labeling · Standard review | Approved | |
| Nov 8, 1999 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1999 | Supplement 29Labeling · Standard review | Approved | None posted |
| Nov 3, 1998 | Supplement 28Labeling · Standard review | Approved | None posted |
| Sep 23, 1998 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Feb 2, 1996 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1995 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1995 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Apr 25, 1994 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Apr 25, 1994 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1985 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1982 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1981 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 5, 1981 | Supplement 13Labeling | Approved | None posted |
| Mar 23, 1981 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1981 | Supplement 15Labeling | Approved | None posted |
| Sep 25, 1980 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1980 | Supplement 9Labeling | Approved | None posted |
| Feb 1, 1980 | Supplement 5Labeling | Approved | None posted |
| Nov 26, 1979 | Supplement 4Labeling | Approved | None posted |
| Oct 26, 1979 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1979 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1979 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
