Application Nr Approved Date Route Status External Links
ANDA076467 2006-03-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Glipizide Extended-Release Tablets Are Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Glipizide Extended-Release Tablets Are A Sulfonylurea Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus ( 1) Limitations Of Use: Not For Treatment Of Type 1 Diabetes Or Diabetic Ketoacidosis ( 1) 1.1 Limitations Of Use Glipizide Extended-Release Tablets Are Not Recommended For The Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Acetyltributyl Citrate ACETYLTRIBUTYL CITRATE Molecular
2. Ammonia AMMONIA Molecular
3. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
5. Hydroxyethyl Cellulose HYDROXYETHYL CELLULOSE Unresolved
6. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
7. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
8. 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.
9. Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) Unresolved
10. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Glipizide GLIPIZIDE ZINC537795

Comments