Application Nr Approved Date Route Status External Links
ANDA203435 2016-06-03 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Norethindrone Acetate And Ethinyl Estradiol Tablets Are An Estrogen Plus Progestin Indicated In A Woman With A Uterus For: Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause (1.1) Prevention Of Postmenopausal Osteoporosis (1.2) 1.1 Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause 1.2 Prevention Of Postmenopausal Osteoporosis Limitation Of Use When Prescribing Solely For The Prevention Of Postmenopausal Osteoporosis, Thera Py Should Only Be Condisered For Women A T Significant Risk Of Osteoporosis And Non-Estrogen Medication Should Be Carefully Considered.

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
2. 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.
3. Ethylcelluloses ETHYLCELLULOSES Unresolved
4. .alpha.-Tocopherol .ALPHA.-TOCOPHEROL Molecular
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
6. Hypromelloses HYPROMELLOSES Unresolved
7. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
8. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
9. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
10. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
11. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Ethinyl Estradiol
2. Norethindrone Acetate

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