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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 086069


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NDA 086069 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 086069
Tradename:ESTRACE
Applicant:Allergan
Ingredient:estradiol
Patents:0
Pharmacology for NDA: 086069
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 086069
Suppliers and Packaging for NDA: 086069
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRACE estradiol CREAM;VAGINAL 086069 ANDA Teva Pharmaceuticals USA, Inc. 0093-3541 0093-3541-43 1 TUBE, WITH APPLICATOR in 1 CARTON (0093-3541-43) / 42.5 g in 1 TUBE, WITH APPLICATOR
ESTRACE estradiol CREAM;VAGINAL 086069 ANDA Allergan, Inc. 0430-3754 0430-3754-14 36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength0.01%
Approval Date:Jan 31, 1984TE:ABRLD:Yes

Expired US Patents for NDA 086069

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ESTRACE estradiol CREAM;VAGINAL 086069-001 Jan 31, 1984 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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