Application Nr Approved Date Route Status External Links
ANDA203315 2017-03-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Exemestane Tablets Are An Aromatase Inhibitor Indicated For: •adjuvant Treatment Of Postmenopausal Women With Estrogen-Receptor Positive Early Breast Cancer Who Have Received Two To Three Years Of Tamoxifen And Are Switched To Exemestane Tablets For Completion Of A Total Of Five Consecutive Years Of Adjuvant Hormonal Therapy (14.1). •treatment Of Advanced Breast Cancer In Postmenopausal Women Whose Disease Has Progressed Following Tamoxifen Therapy (14.2). 1.1 Adjuvant Treatment Of Postmenopausal Women Exemestane Tablets Are Indicated For Adjuvant Treatment Of Postmenopausal Women With Estrogen-Receptor Positive Early Breast Cancer Who Have Received Two To Three Years Of Tamoxifen And Are Switched To Exemestane Tablets For Completion Of A Total Of Five Consecutive Years Of Adjuvant Hormonal Therapy [see Clinical Studies (14.1)]. 1.2 Advanced Breast Cancer In Postmenopausal Women Exemestane Tablets Are Indicated For The Treatment Of Advanced Breast Cancer In Postmenopausal Women Whose Disease Has Progressed Following Tamoxifen Therapy [see Clinical Studies (14.2)].

All Formulated Excipients (13 Total)

Name Structure Kind Function Status
1. Butylated Hydroxyanisole BUTYLATED HYDROXYANISOLE Molecular
2. Butylated Hydroxytoluene BUTYLATED HYDROXYTOLUENE Molecular
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
6. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
7. 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.
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
11. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
12. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
13. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Exemestane EXEMESTANE ZINC3973334

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