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Generated: November 13, 2018

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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. There is one patent protecting this drug. 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. Forty-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:1
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

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Jan 20, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 20, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL AEROSOL HAIR REGROWTH TREATMENT

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Feb 28, 2014TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 20, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL AEROSOL HAIR REGROWTH TREATMENT

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