Manages exogenous obesity. ANDA 40886, held by Kvk Tech. Phentermine Hydrochloride.
As of Nov 15, 2026, ANDA 40886 (Phentermine Hydrochloride), held by Kvk Tech, was first approved by FDA on Mar 31, 2008, with 2 approved supplements and 0 published complete response letters.
Phentermine Hydrochloride, USP 15 mg and 30 mg is 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2008 | Original application | Approved | None posted |
| Phentermine Hydrochloride30MG · capsule;oral | Phentermine Hydrochloride | Rx |
| Phentermine Hydrochloride15MG · capsule;oral | Phentermine Hydrochloride | Rx |
| May 31, 2017 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 5, 2012 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 31, 2008 | 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
