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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 208092

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NDA 208092 describes MINOXIDIL (FOR WOMEN), which is a drug marketed by P And L, Taro, Apotex Inc, Hi Tech Pharma, L Perrigo Co, and Sight Pharms, and is included in six NDAs. It is available from sixteen suppliers. Additional details are available on the MINOXIDIL (FOR WOMEN) profile page.

The generic ingredient in MINOXIDIL (FOR WOMEN) 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 208092
Applicant:P And L
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 208092
Suppliers and Packaging for NDA: 208092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOXIDIL (FOR MEN) minoxidil AEROSOL, FOAM;TOPICAL 208092 ANDA Actavis Pharma, Inc. 0472-1660 0472-1660-60 1 CAN in 1 CARTON (0472-1660-60) > 60 g in 1 CAN
MINOXIDIL (FOR MEN) minoxidil AEROSOL, FOAM;TOPICAL 208092 ANDA Actavis Pharma, Inc. 0472-1660 0472-1660-85 2 CAN in 1 CARTON (0472-1660-85) > 60 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Feb 17, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Jul 27, 2017TE:RLD:No

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