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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075182

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NDA 075182 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 thirty-one 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 075182
Tradename:ESTRADIOL
Applicant:Mylan Technologies
Ingredient:estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 075182
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 075182
Suppliers and Packaging for NDA: 075182
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 075182 ANDA Mylan Pharmaceuticals Inc. 0378-3349 N 0378-3349-99
ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 075182 ANDA Mylan Pharmaceuticals Inc. 0378-3350 N 0378-3350-99

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Feb 24, 2000TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.075MG/24HR
Approval Date:Jan 26, 2005TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.025MG/24HR
Approval Date:Jan 26, 2005TE:AB2RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Daiichi Sankyo
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Colorcon
Farmers Insurance
Fish and Richardson
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Chinese Patent Office

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