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Last Updated: November 30, 2021

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 one supplier. 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 suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 021813
Applicant:Mylan Speciality Lp
Formulation / Manufacturing:see details
Pharmacology for NDA: 021813
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 0037-4801-70 2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) > 35 g in 1 BOTTLE, PUMP (0037-4801-35)

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:⤷  Free Forever TrialPatent Expiration:Jun 25, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?

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