Application Nr Approved Date Route Status External Links
ANDA202463 2012-12-07 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, Usp Are Indicated For The Treatment Of Hypertension. It May Be Used Alone Or In Combination With Other Antihypertensive Medications. Diltiazem Hydrochloride Extended-Release Capsules, Usp Are Indicated For The Management Of Chronic Stable Angina And Angina Due To Coronary Artery Spasm.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. 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.
2. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
3. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

Comments