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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090920

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NDA 090920 describes ESTRADIOL VALERATE, which is a drug marketed by Am Regent, Dr Reddys, Fosun Pharma, Hikma, Watson Labs, and Xiromed, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the ESTRADIOL VALERATE profile page.

The generic ingredient in ESTRADIOL VALERATE 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 090920

Tradename:	ESTRADIOL VALERATE
Applicant:	Am Regent
Ingredient:	estradiol valerate
Patents:	0

Pharmacology for NDA: 090920

Mechanism of Action	Estrogen Receptor Agonists

Suppliers and Packaging for NDA: 090920

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	090920	ANDA	American Regent, Inc.	0517-0420	0517-0420-01	1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE
ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	090920	ANDA	American Regent, Inc.	0517-0440	0517-0440-01	1 VIAL, MULTI-DOSE in 1 CARTON (0517-0440-01) / 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Jan 19, 2010	TE:	AO	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Jan 19, 2010	TE:	AO	RLD:	No

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