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Last Updated: November 23, 2024

Details for New Drug Application (NDA): 209767


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NDA 209767 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 209767
Tradename:ESTRADIOL
Applicant:Alvogen
Ingredient:estradiol
Patents:0
Pharmacology for NDA: 209767
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 209767
Suppliers and Packaging for NDA: 209767
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol CREAM;VAGINAL 209767 ANDA Alvogen Inc. 47781-104 47781-104-44 1 TUBE, WITH APPLICATOR in 1 CARTON (47781-104-44) / 42.5 g in 1 TUBE, WITH APPLICATOR
ESTRADIOL estradiol CREAM;VAGINAL 209767 ANDA A-S Medication Solutions 50090-3645 50090-3645-0 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-3645-0) / 42.5 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength0.01%
Approval Date:Mar 5, 2018TE:ABRLD:No

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