Manages exogenous obesity. ANDA 203068, held by Aurobindo Pharma Ltd. Phentermine Hydrochloride.
As of Nov 15, 2026, ANDA 203068 (Phentermine Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Aug 6, 2014, with 1 approved supplement 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 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). 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phentermine Hydrochloride37.5MG · tablet;oral | Phentermine Hydrochloride | Rx |
| May 31, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 6, 2014 | 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
