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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040114

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NDA 040114 describes ESTRADIOL, which is a drug marketed by Mylan Pharms Inc, Perrigo Uk Finco, Mylan Technologies, Ortho Mcneil Pharm, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Mylan, Usl Pharma, Amneal Pharms, Teva Pharms Usa, Barr, Breckenridge Pharm, Mylan Labs Ltd, Watson Labs, Fosun Pharma, Luitpold, and Watson Labs Inc, and is included in twenty-four NDAs. It is available from thirty-four 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 040114
Tradename:ESTRADIOL
Applicant:Mayne Pharma
Ingredient:estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 040114
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 040114
Suppliers and Packaging for NDA: 040114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol TABLET;ORAL 040114 ANDA Actavis Pharma, Inc. 0591-0487 N 0591-0487-01
ESTRADIOL estradiol TABLET;ORAL 040114 ANDA Actavis Pharma, Inc. 0591-0487 N 0591-0487-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 14, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 14, 1996TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 14, 1996TE:ABRLD:No

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