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Citi
Dow
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AstraZeneca
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US Army
Fuji
QuintilesIMS
Harvard Business School

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090920

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NDA 090920 describes ESTRADIOL VALERATE, which is a drug marketed by Fosun Pharma, Luitpold, Watson Labs, and Watson Labs Inc, and is included in five NDAs. It is available from one supplier. Additional details are available on the ESTRADIOL VALERATE profile page.

The generic ingredient in ESTRADIOL VALERATE 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 090920
Tradename:ESTRADIOL VALERATE
Applicant:Luitpold
Ingredient:estradiol valerate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 090920
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 090920
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 090920 ANDA Perrigo Company 0574-0870 N 0574-0870-05
ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 090920 ANDA Perrigo Company 0574-0872 N 0574-0872-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Jan 19, 2010TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Jan 19, 2010TE:AORLD:No

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Covington
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