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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-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the estradiol profile page.

Summary for NDA: 021166

Tradename:
ESTROGEL
Applicant:
Ascend Theraps Us
Ingredient:
estradiol
Patents:0
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

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 17139-617-20 25 g in 1 BOTTLE, PUMP (17139-617-20)
ESTROGEL
estradiol
GEL, METERED;TRANSDERMAL 021166 NDA ASCEND Therapeutics US, LLC 17139-617 17139-617-40 50 g in 1 BOTTLE, PUMP (17139-617-40)

Summary for product number 001

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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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