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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021813

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NDA 021813 describes ELESTRIN, which is a drug marketed by Mylan Speciality Lp 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-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 021813
Applicant:Mylan Speciality Lp
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
Medical Subject Heading (MeSH) Categories for 021813
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 N 0037-4801-35
ELESTRIN estradiol GEL, METERED;TRANSDERMAL 021813 NDA Meda Pharmaceuticals 0037-4801 N 0037-4801-70

Profile for product number 001

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

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Farmers Insurance
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