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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 214137

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NDA 214137 describes ESTRADIOL, which is a drug marketed by Encube, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Long Grove Pharms, Novitium Pharma, Solaris Pharma Corp, Quagen, Xiromed, Teva Pharms Usa Inc, Ortho Mcneil Pharm, Barr Labs Inc, Epic Pharma Llc, Lannett Co Inc, Pharmobedient, Rubicon Research, Usl Pharma, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Naari Pte, Novast Labs, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in fifty-one NDAs. It is available from thirty-five 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 214137

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

Medical Subject Heading (MeSH) Categories for 214137

Estrogens

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INSERT;VAGINAL			Strength	0.004MG
Approval Date:	Dec 8, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INSERT;VAGINAL			Strength	0.01MG
Approval Date:	Dec 8, 2025	TE:	AB	RLD:	No

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