Last Updated: September 24, 2026

Details for New Drug Application (NDA): 212313

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NDA 212313 describes ESTRADIOL, which is a drug marketed by Encube, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Novitium Pharma, Padagis Us, Solaris Pharma Corp, Xiromed, Teva Pharms Usa Inc, 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, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in fifty-two NDAs. It is available from thirty-six suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL is estradiol valerate. There are six 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 212313

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

Pharmacology for NDA: 212313

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 212313

Estrogens

Suppliers and Packaging for NDA: 212313

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	CREAM;VAGINAL	212313	ANDA	A-S Medication Solutions	50090-6811	50090-6811-0	1 TUBE in 1 CARTON (50090-6811-0) / 42.5 g in 1 TUBE
ESTRADIOL	estradiol	CREAM;VAGINAL	212313	ANDA	Prasco Laboratories	66993-002	66993-002-10	1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;VAGINAL			Strength	0.01%
Approval Date:	Jul 15, 2021	TE:	AB	RLD:	No

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