Application Nr Approved Date Route Status External Links
ANDA075401 2003-04-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. Gelatin GELATIN Unresolved
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. Shellac SHELLAC Unresolved
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. Povidones POVIDONES Unresolved
8. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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