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US Department of Justice

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021166

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NDA 021166 describes ESTROGEL, which is a drug marketed by Ascend Theraps Us and is included in one NDA. It is available from one supplier. Additional details are available on the ESTROGEL profile page.

The generic ingredient in ESTROGEL is estradiol. There are seventy-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 021166
Applicant:Ascend Theraps Us
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 021166
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 021166
Suppliers and Packaging for NDA: 021166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTROGEL estradiol GEL, METERED;TRANSDERMAL 021166 NDA ASCEND Therapeutics US, LLC 17139-617 N 17139-617-40
ESTROGEL estradiol GEL;TOPICAL 021166 NDA ASCEND Therapeutics US, LLC 17139-617 N 17139-617-40

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TOPICALStrength0.06%
Approval Date:Feb 9, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength0.06% (1.25GM/ACTIVATION)
Approval Date:Feb 9, 2004TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

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