Application Nr Approved Date Route Status External Links
ANDA203820 2014-01-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Repaglinide Tablets Are Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Limitation Of Use: Repaglinide Tablets Should Not Be Used In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Diabetic Ketoacidosis. Repaglinide Tablets Are A Glinide Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. (1) Limitation Of Use: Not For Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis (1)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. 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.
5. Meglumine MEGLUMINE Molecular
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Repaglinide REPAGLINIDE ZINC3798537

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