Application Nr Approved Date Route Status External Links
ANDA040197 1997-10-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Estradiol Tablets Usp Are Indicated In The: 1.treatment Of Moderate To Severe Vasomotor Symptoms Associated With The Menopause. 2.treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Associated With The Menopause. When Prescribing Solely For The Treatment Of Symptoms Of Vulvar And Vaginal Atrophy, Topical Vaginal Products Should Be Considered. 3.treatment Of Hypoestrogenism Due To Hypogonadism, Castration Or Primary Ovarian Failure. 4.treatment Of Breast Cancer (for Palliation Only) In Appropriately Selected Women And Men With Metastatic Disease. 5.treatment Of Advanced Androgen-Dependent Carcinoma Of The Prostate (for Palliation Only). 6.prevention Of Osteoporosis. When Prescribing Solely For The Prevention Of Postmenopausal Osteoporosis, Therapy Should Only Be Considered For Women At Significant Risk Of Osteoporosis And For Whom Non-Estrogen Medications Are Not Considered To Be Appropriate. (see Clinical Pharmacology, Clinical Studies.) The Mainstays For Decreasing The Risk Of Postmenopausal Osteoporosis Are Weight Bearing Exercise, Adequate Calcium And Vitamin D Intake, And When Indicated, Pharmacologic Therapy. Postmenopausal Women Require An Average Of 1500 Mg/day Of Elemental Calcium. Therefore, When Not Contraindicated, Calcium Supplementation May Be Helpful For Women With Suboptimal Dietary Intake. Vitamin D Supplementation Of 400 To 800 Iu/day May Also Be Required To Ensure Adequate Daily Intake In Postmenopausal Women.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Estradiol ESTRADIOL ZINC3881556

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