Application Nr Approved Date Route Status External Links
ANDA090492 2011-10-28 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 (16 Total)

Name Structure Kind Function Status
1. Methyl Alcohol METHYL ALCOHOL Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
4. Ethylcelluloses ETHYLCELLULOSES Unresolved
5. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
6. Acetyltributyl Citrate ACETYLTRIBUTYL CITRATE Molecular
7. 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.
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. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Alcohol ALCOHOL Molecular
11. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
12. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
13. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
14. Ammonia AMMONIA Molecular
15. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
16. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

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

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