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Ethinyl estradiol - Generic Drug Details

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Ethinyl estradiol is the generic ingredient in one hundred and eighty-seven branded drugs marketed by Pharmacia And Upjohn, Organon Usa Inc, Schering, Jai Pharma Ltd, Watson Labs, Mayne Pharma, Gd Searle Llc, Barr, Parke Davis, Sandoz, Vintage Pharms Llc, Sandoz Inc, Lupin Ltd, Amneal Pharms, Duramed Pharms Barr, Novast Labs Ltd, Teva Branded Pharm, Glenmark Generics, Bayer Hlthcare, Glenmark Pharms Ltd, Wyeth Pharms Inc, Aurobindo Pharma Ltd, Haupt Pharma, Wyeth Pharms, Mylan Technologies, Janssen Pharms, Ortho Mcneil Pharm, Vintage Pharms, Warner Chilcott Llc, Warner Chilcott, LPI, Allergan Sales Llc, Ortho Mcneil Janssen, Apil, Barr Labs Inc, Lupin Atlantis, Lupin Pharms, Glenmark Pharms, Oc Pharma, and Pelagius, and is included in two hundred and thirty-three NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol. There is one tentative approval for this compound.

Summary for Generic Name: ethinyl estradiol

Drug Master File Entries: see list26
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Drug Prices:see low prices

Tentative approvals for ETHINYL ESTRADIOL

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL0.03MG,0.01MG; 0.15MG,N/A

Clinical Trials for: ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
ethinyl estradiol; norethindrone
TABLET;ORAL-21070684-001Jan 29, 1987DISCNNo
Teva Branded Pharm
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006RXYes7,858,605Jun 23, 2023Y
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 2010RXYes7,704,984Feb 2, 2029
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