Application Nr Approved Date Route Status External Links
NDA020401 1998-10-16 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 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 Are Indicated For The Treatment Of Chronic Stable Angina.

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. D&c Red No. 28 D&C RED NO. 28 Molecular DYE-Dye
2. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye
3. Fd&c Green No. 3 FD&C GREEN NO. 3 Molecular DYE-Dye
4. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
5. Gelatin GELATIN Unresolved
6. Hypromelloses HYPROMELLOSES Unresolved
7. 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.
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Povidones POVIDONES Unresolved
10. Simethicone SIMETHICONE Unresolved
11. Sucrose Stearate SUCROSE STEARATE Molecular
12. 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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