Application Nr Approved Date Route Status External Links
ANDA074984 1999-12-20 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 Are Indicated For The Treatment Of Hypertension. They May Be Used Alone Or In Combination With Other Antihypertensive Medications. Diltiazem Hydrochloride Extended-Release Capsules Are Indicated For The Management Of Chronic Stable Angina And Angina Due To Coronary Artery Spasm.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Gelatin GELATIN Unresolved
4. Shellac SHELLAC Unresolved
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
7. Simethicone SIMETHICONE Unresolved
8. 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.
9. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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