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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 206388

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NDA 206388 describes ESTRADIOL, which is a drug marketed by Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Solaris Pharma Corp, Chemo Research Sl, Novitium Pharma, 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-seven 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 206388

Tradename:	ESTRADIOL
Applicant:	Teva Pharms Usa
Ingredient:	estradiol
Patents:	0

Pharmacology for NDA: 206388

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 206388

Estrogens

Suppliers and Packaging for NDA: 206388

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	TABLET;VAGINAL	206388	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3223	0093-3223-08	8 BLISTER PACK in 1 CARTON (0093-3223-08) / 1 APPLICATOR in 1 BLISTER PACK / 1 INSERT in 1 APPLICATOR
ESTRADIOL	estradiol	TABLET;VAGINAL	206388	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3223	0093-3223-97	18 BLISTER PACK in 1 CARTON (0093-3223-97) / 1 APPLICATOR in 1 BLISTER PACK (0093-3223-19) / 1 INSERT in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;VAGINAL			Strength	10MCG
Approval Date:	Jul 21, 2017	TE:	AB	RLD:	No

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