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Details for Generic Name: drospirenone; ethinyl estradiol

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Summary for Generic Name: drospirenone; ethinyl estradiol

Drug Master File Entries: see list10
Suppliers: see list5

Clinical Trials for: drospirenone; ethinyl estradiol

Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.
Status: Completed Condition: Healthy

Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions
Status: Completed Condition: Healthy

Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
Status: Completed Condition: Polycystic Ovary Syndrome; Estro-progestin Drugs

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Status: Active, not recruiting Condition: Polycystic Ovary Syndrome

Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance
Status: Completed Condition: PCOS; Polycystic Ovary Syndrome

Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
Status: Completed Condition: Contraception

Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne
Status: Completed Condition: Acne Vulgaris

A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS
Status: Terminated Condition: Hidradenitis Suppurativa

Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
Status: Completed Condition: Dysmenorrhea

Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
Status: Active, not recruiting Condition: Polycystic Ovary Syndrome; Endothelial Dysfunction

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574Dec 16, 2010RXYes5,798,338<disabled>Y<disabled>
Bayer Hlthcare
drospirenone; ethinyl estradiol
TABLET;ORAL021676Mar 16, 2006RXYesRE43916<disabled><disabled>
drospirenone; ethinyl estradiol
TABLET;ORAL079221Mar 28, 2011RXNo<disabled><disabled>
Novast Labs Ltd
drospirenone; ethinyl estradiol
TABLET;ORAL-28202015Nov 19, 2014RXNo<disabled><disabled>
drospirenone; ethinyl estradiol
TABLET;ORAL-28090114Mar 28, 2011RXNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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