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Serving leading biopharmaceutical companies globally:

AstraZeneca
Fuji
Express Scripts
Cerilliant
Federal Trade Commission
Cantor Fitzgerald
Queensland Health
Fish and Richardson
Argus Health
Merck

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021180

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NDA 021180 describes ORTHO EVRA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ORTHO EVRA profile page.

The generic ingredient in ORTHO EVRA is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.
Summary for 021180
Tradename:ORTHO EVRA
Applicant:Janssen Pharms
Ingredient:ethinyl estradiol; norelgestromin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021180
Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 021180
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180 NDA Janssen Pharmaceutical, Inc. 50458-192 N 50458-192-24

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 20, 2001TE:RLD:Yes

Expired US Patents for NDA 021180

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Dow
McKesson
US Army
Accenture
Cipla
Medtronic
Merck
Daiichi Sankyo

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