Application Nr Approved Date Route Status External Links
ANDA074910 1997-05-02 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 (twice-A-Day Dosage) Are Indicated For The Treatment Of Hypertension. They May Be Used Alone Or In Combination With Other Antihypertensive Medications, Such As Diuretics.

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Diethyl Phthalate DIETHYL PHTHALATE Molecular
2. Gelatin GELATIN Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Maltodextrin MALTODEXTRIN Unresolved GRAS-Generally recognized as safe.
5. Methacrylic Acid - Methyl Methacrylate Copolymer (1:2) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) Unresolved
6. Shellac SHELLAC Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Povidones POVIDONES Unresolved
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
11. 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.
12. 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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