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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 218507

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NDA 218507 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 218507

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

Pharmacology for NDA: 218507

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 218507

Estrogens

Suppliers and Packaging for NDA: 218507

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	GEL;TRANSDERMAL	218507	ANDA	Encube Ethicals, Inc.	21922-086	21922-086-52	30 PACKET in 1 CARTON (21922-086-52) / .25 g in 1 PACKET
ESTRADIOL	estradiol	GEL;TRANSDERMAL	218507	ANDA	Encube Ethicals, Inc.	21922-087	21922-087-52	30 PACKET in 1 CARTON (21922-087-52) / .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:	Mar 5, 2025	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:	Mar 5, 2025	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:	Mar 5, 2025	TE:	AB	RLD:	No

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