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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Queensland Health
Accenture
Fish and Richardson
Dow
Express Scripts
US Army
Chinese Patent Office
Teva

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205256

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NDA 205256 describes ESTRADIOL, which is a drug marketed by Alvogen Pine Brook, Mylan Pharms Inc, Perrigo Uk Finco, Teva Pharms Usa, Mylan Technologies, Ortho Mcneil Pharm, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Mylan, Usl Pharma, Amneal Pharms, Accord Hlthcare, Barr, Breckenridge Pharm, Mylan Labs Ltd, Watson Labs, Fosun Pharma, Luitpold, and Watson Labs Inc, and is included in twenty-seven NDAs. It is available from twenty-five suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL is estradiol valerate. There are seventy-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.
Summary for 205256
Tradename:ESTRADIOL
Applicant:Amneal Pharms
Ingredient:estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 205256
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 205256
Suppliers and Packaging for NDA: 205256
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol TABLET;VAGINAL 205256 ANDA AvKARE, Inc. 42291-962 N 42291-962-08
ESTRADIOL estradiol TABLET;VAGINAL 205256 ANDA AvKARE, Inc. 42291-962 N 42291-962-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;VAGINALStrength10MCG
Approval Date:May 29, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
US Department of Justice
Cerilliant
QuintilesIMS
Medtronic
Boehringer Ingelheim
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UBS

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