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Generated: November 13, 2018

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Details for New Drug Application (NDA): 020834

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NDA 020834 describes ROGAINE EXTRA STRENGTH (FOR MEN), which is a drug marketed by Johnson And Johnson and is included in one NDA. It is available from two suppliers. Additional details are available on the ROGAINE EXTRA STRENGTH (FOR MEN) profile page.

The generic ingredient in ROGAINE EXTRA STRENGTH (FOR MEN) 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 020834
Tradename:ROGAINE EXTRA STRENGTH (FOR MEN)
Applicant:Johnson And Johnson
Ingredient:minoxidil
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020834
Suppliers and Packaging for NDA: 020834
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROGAINE EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 020834 NDA Johnson & Johnson Consumer Inc. 42002-101 42002-101-02 1 BOTTLE, PLASTIC in 1 CARTON (42002-101-02) > 60 mL in 1 BOTTLE, PLASTIC
ROGAINE EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 020834 NDA Johnson & Johnson Consumer Inc. 42002-101 42002-101-06 3 BOTTLE, PLASTIC in 1 CARTON (42002-101-06) > 60 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength5%
Approval Date:Nov 14, 1997TE:RLD:Yes

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