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Last Updated: December 25, 2024

Details for New Drug Application (NDA): 084500


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NDA 084500 describes ESTRACE, which is a drug marketed by Allergan and Bristol Myers Squibb and is included in four NDAs. It is available from three suppliers. Additional details are available on the ESTRACE profile page.

The generic ingredient in ESTRACE is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 084500
Tradename:ESTRACE
Applicant:Bristol Myers Squibb
Ingredient:estradiol
Patents:0
Medical Subject Heading (MeSH) Categories for 084500

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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