Manages exogenous obesity. ANDA 40228, held by Elite Labs Inc. Phentermine Hydrochloride.
As of Nov 15, 2026, ANDA 40228 (Phentermine Hydrochloride), held by Elite Labs Inc, was first approved by FDA on Jun 19, 1997, with 5 approved supplements and 0 published complete response letters.
Phentermine Hydrochloride Capsules USP, 37.5 mg 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 |
|---|---|---|---|
| Jun 19, 1997 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phentermine Hydrochloride37.5MG · capsule;oral | Phentermine Hydrochloride | Discontinued |
| May 31, 2017 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 14, 2002 | Supplement 4Manufacturing | Approved | None posted |
| Sep 2, 1999 | Supplement 3Manufacturing | Approved | None posted |
| May 7, 1999 | Supplement 2Labeling | Approved | None posted |
| Aug 10, 1998 | Supplement 1Labeling | Approved | None posted |
| Jun 19, 1997 | Original application | 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
