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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 206685


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NDA 206685 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 206685
Tradename:ESTRADIOL
Applicant:Mylan Technologies
Ingredient:estradiol
Patents:0
Pharmacology for NDA: 206685
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 206685
Suppliers and Packaging for NDA: 206685
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 206685 ANDA Mylan Pharmaceuticals Inc. 0378-4619 0378-4619-26 8 POUCH in 1 CARTON (0378-4619-26) / 1 PATCH in 1 POUCH (0378-4619-16) / 3.5 d in 1 PATCH
ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 206685 ANDA Mylan Pharmaceuticals Inc. 0378-4620 0378-4620-26 8 POUCH in 1 CARTON (0378-4620-26) / 1 PATCH in 1 POUCH (0378-4620-16) / 3.5 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.025MG/24HR
Approval Date:Aug 15, 2018TE:AB3RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.0375MG/24HR
Approval Date:Aug 15, 2018TE:AB3RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Aug 15, 2018TE:AB3RLD:No

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