Application Nr Approved Date Route Status External Links
NDA011839 1982-05-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Medroxyprogesterone Acetate Tablets Are Indicated For The Treatment Of Secondary Amenorrhea And Abnormal Uterine Bleeding Due To Hormonal Imbalance In The Absence Of Organic Pathology, Such As Fibroids Or Uterine Cancer. They Are Also Indicated For Use In The Prevention Of Endometrial Hyperplasia In Nonhysterectomized Postmenopausal Women Who Are Receiving Daily Oral Conjugated Estrogens 0.625 Mg Tablets.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
4. Mineral Oil MINERAL OIL Unresolved
5. Sorbic Acid SORBIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
6. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Medroxyprogesterone Acetate MEDROXYPROGESTERONE ACETATE ZINC5224164