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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 205256

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NDA 205256 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 205256

Tradename:	ESTRADIOL
Applicant:	Amneal Pharms
Ingredient:	estradiol
Patents:	0

Pharmacology for NDA: 205256

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 205256

Estrogens

Suppliers and Packaging for NDA: 205256

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	TABLET;VAGINAL	205256	ANDA	AvKARE	42291-962	42291-962-08	8 APPLICATOR in 1 CARTON (42291-962-08) / 1 TABLET in 1 APPLICATOR (42291-962-11)
ESTRADIOL	estradiol	TABLET;VAGINAL	205256	ANDA	AvKARE	42291-962	42291-962-18	18 APPLICATOR in 1 CARTON (42291-962-18) / 1 TABLET in 1 APPLICATOR (42291-962-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;VAGINAL			Strength	10MCG
Approval Date:	May 29, 2015	TE:	AB	RLD:	No

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