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Details for New Drug Application (NDA): 040275

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NDA 040275 describes ESTRADIOL, which is a drug marketed by Mayne Pharma, Mylan, Lannett Holdings Inc, Ortho Mcneil Pharm, Amneal Pharms, Mylan Technologies, Epic Pharma Inc, Barr Labs Inc, Usl Pharma, Breckenridge Pharm, Teva Pharms Usa, Barr, Watson Labs, Luitpold, Sandoz, and Watson Labs Inc, and is included in twenty-one NDAs. It is available from thirty suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL is dienogest; estradiol valerate. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dienogest; estradiol valerate profile page.

Summary for NDA: 040275

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

Pharmacology for NDA: 040275

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 040275

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL
estradiol
TABLET;ORAL 040275 ANDA Heritage Pharmaceuticals Inc 23155-013 23155-013-01 100 TABLET in 1 BOTTLE (23155-013-01)
ESTRADIOL
estradiol
TABLET;ORAL 040275 ANDA Heritage Pharmaceuticals Inc 23155-014 23155-014-01 100 TABLET in 1 BOTTLE (23155-014-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Dec 29, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 29, 1998TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 29, 1998TE:ABRLD:No


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