Application Nr Approved Date Route Status External Links
ANDA202942 2014-02-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Phentermine Hydrochloride Tablets Are 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., 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 Tablets Usp, [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/m2, Or ≥ 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 Tablets Usp, Should Be Measured Against Possible Risk Factors Inherent In Their Use. ( 1 ) Figure 1

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
5. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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