Application Nr Approved Date Route Status External Links
ANDA201212 2010-12-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Diethylpropion Hydrochloride Is Indicated In The Management Of Exogenous Obesity As A Short-Term Adjunct (a Few Weeks) In A Regimen Of Weight Reduction Based On Caloric Restriction In Patients With An Initial Body Mass Index (bmi) Of 30 Kg/m2 Or Higher And Who Have Not Responded To Appropriate Weight Reducing Regimen (diet And/or Exercise) Alone. Below Is A Chart Of 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 Divided By 2.2 = Kg; Inches X 0.0254 = Meters. Body Mass Index (bmi), Kg/m2 Weight (pounds) Height (feet, Inches) 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 The 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. Diethylpropion Hydrochloride Is Indicated For Use As Monotherapy Only.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE 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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Diethylpropion Hydrochloride DIETHYLPROPION HYDROCHLORIDE ZINC215

Comments