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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 040197


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NDA 040197 describes ESTRADIOL, which is a drug marketed by Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Solaris Pharma Corp, Chemo Research Sl, Novitium Pharma, Quagen, Ortho Mcneil Pharm, Barr Labs Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, Norvium Bioscience, Usl Pharma, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Xiromed, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in forty-seven NDAs. It is available from thirty-six 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. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.
Summary for 040197
Tradename:ESTRADIOL
Applicant:Barr Labs Inc
Ingredient:estradiol
Patents:0
Pharmacology for NDA: 040197
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 040197
Suppliers and Packaging for NDA: 040197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol TABLET;ORAL 040197 ANDA Allergan, Inc. 0430-0720 0430-0720-24 100 TABLET in 1 BOTTLE (0430-0720-24)
ESTRADIOL estradiol TABLET;ORAL 040197 ANDA Allergan, Inc. 0430-0721 0430-0721-24 100 TABLET in 1 BOTTLE (0430-0721-24)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 22, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 22, 1997TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 22, 1997TE:ABRLD:No

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