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Generated: September 25, 2017

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Details for New Drug Application (NDA): 040114

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NDA 040114 describes ESTRADIOL, which is a drug marketed by Mayne Pharma, Mylan, Lannett Holdings Inc, Ortho Mcneil Pharm, Amneal Pharms, Mylan Technologies, Epic Pharma Inc, Teva Pharms Usa, Barr Labs Inc, Usl Pharma, Breckenridge Pharm, Mylan Labs Ltd, Barr, Watson Labs, Luitpold, Sandoz Inc, and Watson Labs Inc, and is included in twenty-two 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 NDA: 040114

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: 040114

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

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 Watson Laboratories, Inc. 0591-0487 0591-0487-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0487-01)
ESTRADIOL
estradiol
TABLET;ORAL 040114 ANDA Watson Laboratories, Inc. 0591-0487 0591-0487-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-0487-05)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Daiichi Sankyo
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Dow

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