Application Nr Approved Date Route Status External Links
NDA020364 2006-04-11 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 Capsules Are A Combination Capsule Of Amlodipine, A Dihydropyridine Calcium Channel Blocker (dhp Ccb) And Benazepril, An Angiotensin Converting Enzyme (ace) Inhibitor. Amlodipine Besylate And Benazepril Hydrochloride Capsules Are Indicated For The Treatment Of Hypertension In Patients Not Adequately Controlled On Monotherapy With Either Agent ( ) 1 1.1 Hypertension Amlodipine Besylate And Benazepril Hydrochloride Capsules Are Indicated For The Treatment Of Hypertension In Patients Not Adequately Controlled On Monotherapy With Either Agent.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM 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. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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