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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 216160

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NDA 216160 describes ESTRADIOL, which is a drug marketed by Alvogen, 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, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, Norvium Bioscience, Usl Pharma, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Xiromed, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in forty-eight 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 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 216160

Tradename:	ESTRADIOL
Applicant:	Solaris Pharma Corp
Ingredient:	estradiol
Patents:	0

Pharmacology for NDA: 216160

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 216160

Estrogens

Suppliers and Packaging for NDA: 216160

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	GEL, METERED;TRANSDERMAL	216160	ANDA	Solaris Pharma Corporation	73473-308	73473-308-50	1 BOTTLE, PUMP in 1 CARTON (73473-308-50) / 50 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL, METERED;TRANSDERMAL			Strength	0.06% (1.25GM/ACTIVATION)
Approval Date:	Apr 22, 2024	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Oct 23, 2024
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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