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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021048


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NDA 021048 describes ESTRADIOL, which is a drug marketed by Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Chemo Research Sl, Novitium Pharma, Ortho Mcneil Pharm, Barr Labs Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, Usl Pharma, Amneal Pharms, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Dr Reddys, Am Regent, Fosun Pharma, Hikma, Watson Labs, and Xiromed, and is included in forty-three NDAs. It is available from thirty-two 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 021048
Tradename:ESTRADIOL
Applicant:Ortho Mcneil Pharm
Ingredient:estradiol
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021048

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYSTEM;TRANSDERMALStrength0.05MG/24HR
Approval Date:Sep 20, 1999TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SYSTEM;TRANSDERMALStrength0.075MG/24HR
Approval Date:Sep 20, 1999TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SYSTEM;TRANSDERMALStrength0.1MG/24HR
Approval Date:Sep 20, 1999TE:RLD:No

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