Application Nr Approved Date Route Status External Links
ANDA080172 1993-12-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Propylthiouracil Tablets, Usp Are Indicated: In Patients With Graves’ Disease With Hyperthyroidism Or Toxic Multinodular Goiter Who Are Intolerant Of Methimazole And For Whom Surgery Or Radioactive Iodine Therapy Is Not An Appropriate Treatment Option To Ameliorate Symptoms Of Hyperthyroidism In Preparation For Thyroidectomy Or Radioactive Iodine Therapy In Patients Who Are Intolerant Of Methimazole

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Propylthiouracil PROPYLTHIOURACIL ZINC4640636