Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021812

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MEN'S ROGAINE (MINOXIDIL)
5% Marketing Status: Over-the-counter

Active Ingredient: MINOXIDIL
Proprietary Name: MEN'S ROGAINE
Dosage Form; Route of Administration: AEROSOL, FOAM; TOPICAL
Strength: 5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021812
Product Number: 001
Approval Date: Jan 20, 2006
Applicant Holder Full Name: JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

WOMEN'S ROGAINE (MINOXIDIL)
5% Marketing Status: Over-the-counter

Active Ingredient: MINOXIDIL
Proprietary Name: WOMEN'S ROGAINE
Dosage Form; Route of Administration: AEROSOL, FOAM; TOPICAL
Strength: 5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021812
Product Number: 002
Approval Date: Feb 28, 2014
Applicant Holder Full Name: JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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