Adipex-P

Product manufactured by Teva Select Brands

Application Nr Approved Date Route Status External Links
ANDA085128 2013-10-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Adipex-P® 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 Adipex-P®, [see Clinical Pharmacology (12.1, 12.2)] Should Be Measured Against Possible Risk Factors Inherent In Their Use Such As Those Described Below. Adipex-P® 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 Adipex-P®, Should Be Measured Against Possible Risk Factors Inherent In Their Use. (1) Figure 1

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Gelatin GELATIN Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

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

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