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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021812


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NDA 021812 describes WOMEN'S ROGAINE, which is a drug marketed by Johnson And Johnson and is included in one NDA. It is available from one supplier. Additional details are available on the WOMEN'S ROGAINE profile page.

The generic ingredient in WOMEN'S ROGAINE is minoxidil. There are eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 021812
Tradename:WOMEN'S ROGAINE
Applicant:Johnson And Johnson
Ingredient:minoxidil
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021812
Suppliers and Packaging for NDA: 021812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEN'S ROGAINE minoxidil AEROSOL, FOAM;TOPICAL 021812 NDA Johnson & Johnson Consumer Inc. 69968-0030 69968-0030-1 1 CAN in 1 CARTON (69968-0030-1) > 60 g in 1 CAN
MEN'S ROGAINE minoxidil AEROSOL, FOAM;TOPICAL 021812 NDA Johnson & Johnson Consumer Inc. 69968-0030 69968-0030-2 2 CAN in 1 CARTON (69968-0030-2) > 60 g in 1 CAN
Paragraph IV (Patent) Challenges for 021812
Tradename Dosage Ingredient NDA Submissiondate
MEN'S ROGAINE AEROSOL, FOAM;TOPICAL minoxidil 021812 2009-04-06
WOMEN'S ROGAINE AEROSOL, FOAM;TOPICAL minoxidil 021812 2009-04-06

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Jan 20, 2006TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Feb 28, 2014TE:RLD:Yes

Expired US Patents for NDA 021812

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Johnson And Johnson MEN'S ROGAINE minoxidil AEROSOL, FOAM;TOPICAL 021812-001 Jan 20, 2006   Start Trial   Start Trial
Johnson And Johnson WOMEN'S ROGAINE minoxidil AEROSOL, FOAM;TOPICAL 021812-002 Feb 28, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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