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Last Updated: March 17, 2026

Details for New Drug Application (NDA): 216055

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NDA 216055 describes ESTRADIOL, which is a drug marketed by Encube, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Long Grove Pharms, Novitium Pharma, Solaris Pharma Corp, Quagen, 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-one 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 216055

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

Pharmacology for NDA: 216055

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 216055

Estrogens

Suppliers and Packaging for NDA: 216055

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	GEL;TRANSDERMAL	216055	ANDA	Amneal Pharmaceuticals NY LLC	69238-2448	69238-2448-3	30 PACKET in 1 CARTON (69238-2448-3) / 1.25 g in 1 PACKET (69238-2448-1)
ESTRADIOL	estradiol	GEL;TRANSDERMAL	216055	ANDA	Amneal Pharmaceuticals NY LLC	69238-2449	69238-2449-3	30 PACKET in 1 CARTON (69238-2449-3) / 1 g in 1 PACKET (69238-2449-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	0.1% (0.25GM/PACKET)
Approval Date:	Jul 12, 2024	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:	Jul 12, 2024	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:	Jul 12, 2024	TE:	AB	RLD:	No

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