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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 216524

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NDA 216524 describes ESTRADIOL, which is a drug marketed by Encube, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Novitium Pharma, Solaris Pharma Corp, Chemo Research Sl, Quagen, 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, Xiromed, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in forty-nine NDAs. It is available from thirty-five suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL 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 216524

Tradename:	ESTRADIOL
Applicant:	Padagis Israel
Ingredient:	estradiol
Patents:	0

Pharmacology for NDA: 216524

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 216524

Estrogens

Suppliers and Packaging for NDA: 216524

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	GEL;TRANSDERMAL	216524	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-134	45802-134-30	30 PACKET in 1 CARTON (45802-134-30) / .25 g in 1 PACKET
ESTRADIOL	estradiol	GEL;TRANSDERMAL	216524	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-202	45802-202-30	30 PACKET in 1 CARTON (45802-202-30) / .5 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	0.1% (0.25GM/PACKET)
Approval Date:	Nov 14, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	0.1% (0.5GM/PACKET)
Approval Date:	Nov 14, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	0.1% (0.75GM/PACKET)
Approval Date:	Nov 14, 2023	TE:	AB	RLD:	No

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