Manages exogenous obesity. ANDA 40377, held by Prinston. Phentermine Hydrochloride.
As of Nov 15, 2026, ANDA 40377 (Phentermine Hydrochloride), held by Prinston, was first approved by FDA on Jan 4, 2002, with 3 approved supplements and 0 published complete response letters.
Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m 2, or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 4, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phentermine Hydrochloride37.5MG · tablet;oral | Phentermine Hydrochloride | Rx |
| May 31, 2017 | Supplement 14Labeling · Standard review | Approved | None posted |
| Dec 6, 2012 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 6, 2012 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 4, 2002 | Original application | Approved |
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
