Application Nr Approved Date Route Status External Links
ANDA075124 1998-03-18 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. Diltiazem Hydrochloride Extended-Release Capsules (once-A-Day Dosage) May Be Used Alone Or In Combination With Other Antihypertensive Medications, Such As Diuretics. Diltiazem Hydrochloride Extended-Release Capsules (once-A-Day Dosage) Are Indicated For The Management Of Chronic Stable Angina.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Dibutyl Sebacate DIBUTYL SEBACATE Molecular
4. Ethylcelluloses ETHYLCELLULOSES Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. 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.
7. Maltodextrin MALTODEXTRIN Unresolved GRAS-Generally recognized as safe.
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Oleic Acid OLEIC ACID Molecular CTG-Component or coating , MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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