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Details for New Drug Application (NDA): 021813

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NDA 021813 describes ELESTRIN, which is a drug marketed by Meda Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the ELESTRIN profile page.

The generic ingredient in ELESTRIN 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: 021813

Tradename:
ELESTRIN
Applicant:
Meda Pharms
Ingredient:
estradiol
Patents:2
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021813

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 021813

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELESTRIN
estradiol
GEL, METERED;TRANSDERMAL 021813 NDA MEDA Pharmaceuticals 0037-4801 0037-4801-35 1 BOTTLE, PUMP in 1 CARTON (0037-4801-35) > 35 g in 1 BOTTLE, PUMP
ELESTRIN
estradiol
GEL, METERED;TRANSDERMAL 021813 NDA MEDA Pharmaceuticals 0037-4802 0037-4802-35 1 BOTTLE, PUMP in 1 CARTON (0037-4802-35) > 35 g in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength0.06% (0.87GM/ACTIVATION)
Approval Date:Dec 15, 2006TE:RLD:Yes
Patent:7,198,801Patent Expiration:Jun 25, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,470,433Patent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?


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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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