Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021048

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NDA 021048 describes ESTRADIOL, which is a drug marketed by Encube, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Novitium Pharma, Padagis Us, Solaris Pharma Corp, 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-two 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 six 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

Medical Subject Heading (MeSH) Categories for 021048

Estrogens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.05MG/24HR
Approval Date:	Sep 20, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.075MG/24HR
Approval Date:	Sep 20, 1999	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.1MG/24HR
Approval Date:	Sep 20, 1999	TE:		RLD:	No

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