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Details for New Drug Application (NDA): 086069

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NDA 086069 describes ESTRACE, which is a drug marketed by Bristol Myers Squibb and Allergan Sales Llc and is included in four NDAs. It is available from one supplier. Additional details are available on the ESTRACE profile page.

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

Summary for NDA: 086069

Pharmacology for NDA: 086069

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 086069

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
CREAM;VAGINAL 086069 ANDA Allergan, Inc. 0430-3754 0430-3754-95 48 CARTON in 1 CASE (0430-3754-95) > 1 TUBE, WITH APPLICATOR in 1 CARTON > 12 g in 1 TUBE, WITH APPLICATOR

Summary for product number 001

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

Expired Orange Book Patents for NDA: 086069

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