Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
McKesson
Medtronic
Cipla
Mallinckrodt
AstraZeneca
Accenture
Covington
Dow
UBS

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200910

« Back to Dashboard

NDA 200910 describes XULANE, which is a drug marketed by Mylan Technologies and is included in one NDA. It is available from one supplier. Additional details are available on the XULANE profile page.

The generic ingredient in XULANE 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 200910
Tradename:XULANE
Applicant:Mylan Technologies
Ingredient:ethinyl estradiol; norelgestromin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200910
Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 200910
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XULANE ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 200910 ANDA Mylan Pharmaceuticals Inc. 0378-3340 0378-3340-53 3 POUCH in 1 CARTON (0378-3340-53) > 1 PATCH in 1 POUCH (0378-3340-16) > 7 d in 1 PATCH
XULANE ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 200910 ANDA Mylan Pharmaceuticals Inc. 0378-3340 0378-3340-32 1 POUCH in 1 CARTON (0378-3340-32) > 1 PATCH in 1 POUCH (0378-3340-17) > 7 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.035MG/24HR;0.15MG/24HR
Approval Date:Apr 16, 2014TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
Argus Health
Mallinckrodt
Boehringer Ingelheim
Baxter
Cipla
Cerilliant
Fish and Richardson
QuintilesIMS

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.

botpot