Application Nr Approved Date Route Status External Links
NDA004782 2003-07-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Premarin Is A Mixture Of Estrogens Indicated For: Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause (1.1) Treatment Of Moderate To Severe Vulvar And Vaginal Atrophy Due To Menopause (1.2) Treatment Of Hypoestrogenism Due To Hypogonadism, Castration Or Primary Ovarian Failure (1.3) Treatment Of Breast Cancer (for Palliation Only) In Appropriately Selected Women And Men With Metastatic Disease (1.4) Treatment Of Advanced Androgen-Dependent Carcinoma Of The Prostate (for Palliation Only) (1.5) Prevention Of Postmenopausal Osteoporosis (1.6) 1.1 Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause 1.2 Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause Limitation Of Use When Prescribing Solely For The Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause, Topical Vaginal Products Should Be Considered. 1.3 Treatment Of Hypoestrogenism Due To Hypogonadism, Castration Or Primary Ovarian Failure 1.4 Treatment Of Breast Cancer (for Palliation Only) In Appropriately Selected Women And Men With Metastatic Disease 1.5 Treatment Of Advanced Androgen-Dependent Carcinoma Of The Prostate (for Palliation Only) 1.6 Prevention Of Postmenopausal Osteoporosis Limitation Of Use When Prescribing Solely For The Prevention Of Postmenopausal Osteoporosis, Therapy Should Only Be Considered For Women At Significant Risk Of Osteoporosis And Non-Estrogen Medication Should Be Carefully Considered

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Powdered Cellulose POWDERED CELLULOSE Unresolved
8. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Estrogens, Conjugated

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