Application Nr Approved Date Route Status External Links
NDA022247 2013-10-03 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Duavee Is Indicated In Women With A Uterus For: Duavee Is A Combination Of Conjugated Estrogens With An Estrogen Agonist/antagonist Indicated For Treatment Of The Following Conditions In Women With A Uterus: Treatment Of Moderate To Severe Vasomotor Symptoms Associated With Menopause (1.1) Prevention Of Postmenopausal Osteoporosis (1.2) Limitation Of Use: Duavee Should Be Used For The Shortest Duration Consistent With Treatment Goals And Risks For The Individual Woman (1.3) 1.1 Treatment Of Moderate To Severe Vasomotor Symptoms Associated With Menopause 1.2 Prevention Of Postmenopausal Osteoporosis 1.3 Important Limitations Of Use Use Duavee For The Shortest Duration Consistent With Treatment Goals And Risks For The Individual Woman. Postmenopausal Women Should Be Re-Evaluated Periodically As Clinically Appropriate To Determine If Treatment Is Still Necessary. 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 (17 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Powdered Cellulose POWDERED CELLULOSE Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
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. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
8. Ascorbic Acid ASCORBIC ACID Molecular DS-Dietary supplement , MISC-Miscellaneous , NUTR-Nutrient , PRES-Chemical preservative FS-Substances permitted as optional ingredient in a standardized food.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Ferric Oxide Red FERRIC OXIDE RED Molecular
11. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
12. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
13. Povidones POVIDONES Unresolved
14. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
15. Maltitol MALTITOL Molecular
16. Poloxamer 188 POLOXAMER 188 Unresolved
17. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 2 Total)

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