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

1 Indications And Usage 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/m2, Or Greater Than Or Equal To 27 Kg/m2 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. The Limited Usefulness Of Agents Of This Class, Including Phentermine Hydrochloride, [see Clinical Pharmacology ( 12.1 , 12.2 )] Should Be Measured Against Possible Risk Factors Inherent In Their Use Such As Those Described Below. Phentermine Hydrochloride Is A Sympathomimetic Amine Anorectic Indicated As A Short-Term Adjunct (a Few Weeks) 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/m2, Or Greater Than Or Equal To 27 Kg/m2 In The Presence Of Other Risk Factors (e.g., Controlled Hypertension, Diabetes, Hyperlipidemia). (1) The Limited Usefulness Of Agents Of This Class, Including Phentermine Hydrochloride, Should Be Measured Against Possible Risk Factors Inherent In Their Use. (1)

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Gelatin GELATIN Unresolved

Active Ingredients ( 1 Total)

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

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