Application Nr Approved Date Route Status External Links
ANDA075116 1999-12-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Diltiazem Hydrochloride Extended-Release Capsules (once-A-Day Dosage) Are Indicated For The Treatment Of Hypertension. It May Be Used Alone Or In Combination With Other Antihypertensive Medications. Diltiazem Hydrochloride Extended-Release Capsules (once-A-Day Dosage) Are Indicated For The Management Of Chronic Stable Angina And Angina Due To Coronary Artery Spasm.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Povidones POVIDONES Unresolved
6. Simethicone SIMETHICONE Unresolved
7. Sucrose Stearate SUCROSE STEARATE Molecular
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE ZINC621893

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