Application Nr Approved Date Route Status External Links
ANDA078466 2011-07-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Amlodipine Besylate And Benazepril Hydrochloride Capsule Is A Combination Tablet Of Amlodipine, A Dihydropyridine Calcium Channel Blocker (dhp Ccb) And Benazepril, An Angiotensin Converting Enzyme (ace) Inhibitor. Amlodipine Besylate And Benazepril Hydrochloride Is Indicated For The Treatment Of Hypertension (1) In Patients Not Adequately Controlled On Monotherapy With Either Agent. 1.1 Hypertension Amlodipine Besylate And Benazepril Hydrochloride Is Indicated For The Treatment Of Hypertension In Patients Not Adequately Controlled On Monotherapy With Either Agent.

All Formulated Excipients (10 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.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Povidones POVIDONES Unresolved
5. Gelatin GELATIN Unresolved
6. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
7. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
8. Shellac SHELLAC Unresolved
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 2 Total)

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