Application Nr Approved Date Route Status External Links
ANDA075796 2001-04-30 None DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Prempro/premphase Is An Estrogen/progestin Indicated In Women With Intact Uteri 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) Prevention Of Postmenopausal Osteoporosis (1.3) 1.1 Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause 1.2 Treatment Of Moderate To Severe Vulvar And Vaginal Atrophy Due To Menopause 1.3 Prevention Of Postmenopausal Osteoporosis

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
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.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Povidones POVIDONES Unresolved
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
9. Ferric Oxide Red FERRIC OXIDE RED Unresolved
10. Ferric Oxide Yellow FERRIC OXIDE YELLOW Unresolved

Active Ingredients ( 1 Total)

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