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ESTRACE Drug Profile

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Estrace is a drug marketed by Bristol Myers Squibb and Allergan Sales Llc and is included in four NDAs. It is available from one supplier.

The generic ingredient in ESTRACE is estradiol. There are seventy-four drug master file entries for this compound. Forty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the estradiol profile page.

Summary for Tradename: ESTRACE

Patents:0
Applicants:2
NDAs:4
Suppliers / Packagers: see list1

Pharmacology for Tradename: ESTRACE

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: ESTRACE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
ESTRACE
estradiol
TABLET;ORAL084500-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Bristol Myers Squibb
ESTRACE
estradiol
TABLET;ORAL084499-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Allergan Sales Llc
ESTRACE
estradiol
CREAM;VAGINAL086069-001Jan 31, 1984RXYes<disabled><disabled>
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Expired Patents for Tradename: ESTRACE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
ESTRACE
estradiol
CREAM;VAGINAL086069-001Jan 31, 19844,436,738<disabled>
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