Application Nr Approved Date Route Status External Links
NDA200063 2014-09-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Contrave Is Indicated As An Adjunct To A Reduced-Calorie Diet And Increased Physical Activity For Chronic Weight Management In Adults With An Initial Body Mass Index (bmi) Of: 30 Kg/m 2 Or Greater (obese) Or 27 Kg/m 2 Or Greater (overweight) In The Presence Of At Least One Weight-Related Comorbid Condition (e.g., Hypertension, Type 2 Diabetes Mellitus, Or Dyslipidemia). Limitations Of Use: The Effect Of Contrave On Cardiovascular Morbidity And Mortality Has Not Been Established. The Safety And Effectiveness Of Contrave In Combination With Other Products Intended For Weight Loss, Including Prescription Drugs, Over-The-Counter Drugs, And Herbal Preparations, Have Not Been Established. Contrave Is A Combination Of Naltrexone, An Opioid Antagonist, And Bupropion, An Aminoketone Antidepressant, Indicated As An Adjunct To A Reduced-Calorie Diet And Increased Physical Activity For Chronic Weight Management In Adults With An Initial Body Mass Index (bmi) Of: 30 Kg/m 2 Or Greater (obese) Or 27 Kg/m 2 Or Greater (overweight) In The Presence Of At Least One Weight-Related Comorbidity (e.g., Hypertension, Type 2 Diabetes Mellitus, Or Dyslipidemia). ( 1) Limitations Of Use: The Effect Of Contrave On Cardiovascular Morbidity And Mortality Has Not Been Established. ( 1) The Safety And Effectiveness Of Contrave In Combination With Other Products Intended For Weight Loss, Including Prescription And Over-The-Counter Drugs, And Herbal Preparations, Have Not Been Established. ( 1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
3. Cysteine Hydrochloride Anhydrous CYSTEINE HYDROCHLORIDE ANHYDROUS Molecular
4. 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.
5. Hypromelloses HYPROMELLOSES Unresolved
6. Edetate Disodium EDETATE DISODIUM Molecular
7. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
8. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

Comments