Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Harvard Business School
McKinsey
Colorcon
Merck

Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021813


Email this page to a colleague

« Back to Dashboard

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
Tradename:ELESTRIN
Applicant:Mylan Speciality Lp
Ingredient:estradiol
Patents:2
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?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
McKinsey
Colorcon
Dow
Moodys

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 verification 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.