Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Covington
QuintilesIMS
Accenture
Chubb
Johnson and Johnson
Colorcon
Mallinckrodt
Cantor Fitzgerald
Deloitte

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086069

« Back to Dashboard

NDA 086069 describes ESTRACE, which is a drug marketed by Allergan Sales Llc and Bristol Myers Squibb and is included in four NDAs. It is available from two 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-five suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 086069
Tradename:ESTRACE
Applicant:Allergan Sales Llc
Ingredient:estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 086069
Ingredient-typeEstradiol Congeners
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 N 0093-3541-43
ESTRACE estradiol CREAM;VAGINAL 086069 ANDA Allergan, Inc. 0430-3754 N 0430-3754-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength0.01%
Approval Date:Jan 31, 1984TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
US Army
Dow
Fish and Richardson
Chinese Patent Office
Moodys
Argus Health
Farmers Insurance
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.