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Last Updated: April 18, 2021

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Details for New Drug Application (NDA): 209767

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NDA 209767 describes ESTRADIOL, which is a drug marketed by Alvogen Pine Brook, Mylan, Perrigo Uk Finco, Teva Pharms Usa, Amneal, Mylan Technologies, Ortho Mcneil Pharm, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Usl Pharma, Amneal Pharms, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in thirty-three NDAs. It is available from twenty-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 209767
Tradename:ESTRADIOL
Applicant:Alvogen Pine Brook
Ingredient:estradiol
Patents:0
Formulation / Manufacturing:see details
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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