Application Nr Approved Date Route Status External Links
ANDA075269 2000-12-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Nifedipine Extended-Release Tablets Are Indicated For The Treatment Of Hypertension. It May Be Used Alone Or In Combination With Other Antihypertensive Agents.

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Ethylcelluloses ETHYLCELLULOSES Unresolved
2. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
3. Hydroxyethyl Cellulose HYDROXYETHYL CELLULOSE Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
10. 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.
11. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nifedipine NIFEDIPINE ZINC85205448

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