Application Nr Approved Date Route Status External Links
ANDA091022 2012-09-28 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 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 Are Indicated For The Treatment Of Chronic Stable Angina.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Ammonio Methacrylate Copolymer AMMONIO METHACRYLATE COPOLYMER Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Gelatin GELATIN Unresolved
4. 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.
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
6. 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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