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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 210194


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NDA 210194 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 210194
Tradename:ESTRADIOL
Applicant:Padagis Israel
Ingredient:estradiol
Patents:0
Pharmacology for NDA: 210194
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 210194
Suppliers and Packaging for NDA: 210194
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol CREAM;VAGINAL 210194 ANDA AvKARE 42291-426 42291-426-42 1 TUBE in 1 CARTON (42291-426-42) / 42.5 g in 1 TUBE
ESTRADIOL estradiol CREAM;VAGINAL 210194 ANDA Padagis Israel Pharmaceuticals Ltd 45802-097 45802-097-35 1 TUBE in 1 CARTON (45802-097-35) / 42.5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength0.01%
Approval Date:Jan 22, 2018TE:ABRLD:No

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