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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040326

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NDA 040326 describes ESTRADIOL, which is a drug marketed by 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, Luitpold, Sandoz Inc, and Watson Labs Inc, and is included in twenty-two NDAs. It is available from thirty-three 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 040326

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 040326

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 040326

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol TABLET;ORAL 040326 ANDA KAISER FOUNDATION HOSPITALS 0179-0073 0179-0073-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0073-70)
ESTRADIOL estradiol TABLET;ORAL 040326 ANDA KAISER FOUNDATION HOSPITALS 0179-0074 0179-0074-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0074-70)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Apr 21, 1999TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Apr 21, 1999TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 21, 1999TE:ABRLD:No


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