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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. There is one patent protecting this drug and one Paragraph IV challenge. 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. Three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.

Summary for NDA: 021180

Tradename:
ORTHO EVRA
Applicant:
Janssen Pharms
Ingredient:
ethinyl estradiol; norelgestromin
Patents:1
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 50458-192-01 7 d in 1 PATCH (50458-192-01)
ORTHO EVRA
ethinyl estradiol; norelgestromin
FILM, EXTENDED RELEASE;TRANSDERMAL 021180 NDA Janssen Pharmaceutical, Inc. 50458-192 50458-192-15 3 PATCH in 1 CARTON (50458-192-15) > 7 d in 1 PATCH

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:5,876,746Patent Expiration:Nov 20, 2015Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF OVULATION IN A WOMAN

Expired Orange Book 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;TRANSDERMAL021180-001Nov 20, 20015,876,746► subscribe
Janssen Pharms
ORTHO EVRA
ethinyl estradiol; norelgestromin
FILM, EXTENDED RELEASE;TRANSDERMAL021180-001Nov 20, 20015,972,377► subscribe
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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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