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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 210488

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NDA 210488 describes ESTRADIOL, which is a drug marketed by Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Novitium Pharma, Solaris Pharma Corp, Chemo Research Sl, 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-eight 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 210488

Tradename:	ESTRADIOL
Applicant:	Teva Pharms Usa
Ingredient:	estradiol
Patents:	0

Medical Subject Heading (MeSH) Categories for 210488

Estrogens

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;VAGINAL			Strength	0.01%
Approval Date:	Mar 30, 2018	TE:	AB	RLD:	No

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