Application Nr Approved Date Route Status External Links
ANDA040886 2008-03-31 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Phentermine Hydrochloride 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 ≥ 30 Kg/m2, Or ≥ 27 Kg/m2 In The Presence Of Other Risk Factors (e.g., 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 × 0.0254 = Meters. The Limited Usefulness Of Agents Of This Class (see Clinical Pharmacology) Should Be Measured Against Possible Risk Factors Inherent In Their Use Such As Those Described Below. Image Of Table

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Gelatin GELATIN Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE ZINC8403947