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Last Updated: December 12, 2025

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-eight 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 Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 086069

Estrogens

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:	RX	Dosage:	CREAM;VAGINAL			Strength	0.01%
Approval Date:	Jan 31, 1984	TE:	AB	RLD:	Yes

Expired US Patents for NDA 086069

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ESTRACE	estradiol	CREAM;VAGINAL	086069-001	Jan 31, 1984	4,436,738	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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