Application Nr Approved Date Route Status External Links
ANDA040526 2003-10-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 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/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 × 0.0254 = Meters. Body Mass Index (bmi), Kg/m 2 The Limited Usefulness Of Agents Of This Class, Including Phentermine Hydrochloride Tablets, [ 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 ≥ 30 Kg/m 2, Or ≥ 27 Kg/m 2 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) Bmi Figure

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Calcium Phosphate, Dibasic, Dihydrate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE Molecular
2. 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.
3. Povidones POVIDONES Unresolved
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

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

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