Last Updated: September 24, 2026

Details for New Drug Application (NDA): 203723


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NDA 203723 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 203723
Tradename:ESTRADIOL VALERATE
Applicant:Hikma
Ingredient:estradiol valerate
Patents:0
Pharmacology for NDA: 203723
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 203723
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 203723 ANDA Hikma Pharmaceuticals USA Inc. 0143-9289 0143-9289-01 1 VIAL in 1 CARTON (0143-9289-01) / 5 mL in 1 VIAL
ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 203723 ANDA Hikma Pharmaceuticals USA Inc. 0143-9290 0143-9290-01 1 VIAL in 1 CARTON (0143-9290-01) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 21, 2020TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Apr 21, 2020TE:AORLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Apr 21, 2020TE:AORLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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