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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216656


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NDA 216656 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 216656
Tradename:ESTRADIOL VALERATE
Applicant:Xiromed
Ingredient:estradiol valerate
Patents:0
Pharmacology for NDA: 216656
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 216656
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 216656 ANDA Xiromed, LLC 70700-273 70700-273-22 5 mL in 1 VIAL, MULTI-DOSE (70700-273-22)
ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 216656 ANDA Xiromed, LLC 70700-274 70700-274-22 5 mL in 1 VIAL, MULTI-DOSE (70700-274-22)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 28, 2023TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Apr 28, 2023TE:AORLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Apr 28, 2023TE:AORLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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