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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 211396

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NDA 211396 describes ESTRADIOL, which is a drug marketed by Encube, 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, 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, Xiromed, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in forty-nine 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 211396

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

Pharmacology for NDA: 211396

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 211396

Estrogens

Suppliers and Packaging for NDA: 211396

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	211396	ANDA	Amneal Pharmaceuticals LLC	65162-126	65162-126-08	8 POUCH in 1 CARTON (65162-126-08) / 1 d in 1 POUCH (65162-126-04)
ESTRADIOL	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	211396	ANDA	Amneal Pharmaceuticals LLC	65162-148	65162-148-08	8 POUCH in 1 CARTON (65162-148-08) / 1 d in 1 POUCH (65162-148-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.025MG/24HR
Approval Date:	Sep 28, 2020	TE:	AB3	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.0375MG/24HR
Approval Date:	Sep 28, 2020	TE:	AB3	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.05MG/24HR
Approval Date:	Sep 28, 2020	TE:	AB3	RLD:	No

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