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Generated: May 25, 2019

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Details for New Drug Application (NDA): 019501

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NDA 019501 describes ROGAINE (FOR WOMEN), 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 ROGAINE (FOR WOMEN) profile page.

The generic ingredient in ROGAINE (FOR WOMEN) is minoxidil. There are eight drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 019501
Tradename:ROGAINE (FOR WOMEN)
Applicant:Johnson And Johnson
Ingredient:minoxidil
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019501
Suppliers and Packaging for NDA: 019501
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROGAINE (FOR MEN) minoxidil SOLUTION;TOPICAL 019501 NDA Johnson & Johnson Consumer Inc. 69968-0090 69968-0090-1 1 BOTTLE, PLASTIC in 1 CARTON (69968-0090-1) > 60 mL in 1 BOTTLE, PLASTIC
ROGAINE (FOR MEN) minoxidil SOLUTION;TOPICAL 019501 NDA Johnson & Johnson Consumer Inc. 69968-0090 69968-0090-3 3 BOTTLE, PLASTIC in 1 CARTON (69968-0090-3) > 60 mL in 1 BOTTLE, PLASTIC

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength2%
Approval Date:Feb 9, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength2%
Approval Date:Feb 9, 1996TE:RLD:Yes

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