Last Updated: September 24, 2026

Details for New Drug Application (NDA): 083714

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NDA 083714 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 is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.

Summary for 083714

Tradename:	ESTRADIOL VALERATE
Applicant:	Dr Reddys
Ingredient:	estradiol valerate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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