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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 040197

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NDA 040197 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 040197

Tradename:	ESTRADIOL
Applicant:	Barr Labs Inc
Ingredient:	estradiol
Patents:	0

Pharmacology for NDA: 040197

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 040197

Estrogens

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	Teva Pharmaceuticals USA, Inc.	0555-0886	0555-0886-02	100 TABLET in 1 BOTTLE (0555-0886-02)
ESTRADIOL	estradiol	TABLET;ORAL	040197	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0886	0555-0886-04	500 TABLET in 1 BOTTLE (0555-0886-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 22, 1997	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 22, 1997	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 22, 1997	TE:	AB	RLD:	No

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