Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 021812
Company: KENVUE BRANDS

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	None	Yes	Yes
WOMEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	None	Yes	Yes

Showing 1 to 2 of 2 entries

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
01/20/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review	Label for Men's Rogaine

Showing 1 to 1 of 1 entries

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
12/29/2020	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)
01/31/2020	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)
06/11/2019	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)	Label for Women’s Rogaine
02/10/2015	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)	Label for Women’s Rogaine
02/28/2014	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)	Label for Women's Rogaine
12/13/2013	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)	Label for Men’s Rogaine
11/30/2012	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/22/2006	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.

Showing 1 to 8 of 8 entries

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
12/29/2020	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)
01/31/2020	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)
06/11/2019	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)	Label for Women’s Rogaine
06/11/2019	SUPPL-14	Labeling-Package Insert	Label (PDF)	Label for Women’s Rogaine
02/10/2015	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)	Label for Women’s Rogaine
02/28/2014	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)	Label for Women's Rogaine
12/13/2013	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)	Label for Men’s Rogaine
01/20/2006	ORIG-1	Approval	Label (PDF)	Label for Men's Rogaine

Showing 1 to 8 of 8 entries

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	Yes	021812	KENVUE BRANDS
MINOXIDIL	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	091344	PERRIGO PHARMA INTL
MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	218616	AUROBINDO PHARMA
MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	208092	P AND L
MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	209074	TARO
MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	218616	AUROBINDO PHARMA
MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	208092	P AND L
MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	209074	TARO
WOMEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	Yes	021812	KENVUE BRANDS

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	Yes	021812	KENVUE BRANDS
MINOXIDIL	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	091344	PERRIGO PHARMA INTL
MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	218616	AUROBINDO PHARMA
MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	208092	P AND L
MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	209074	TARO
MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	218616	AUROBINDO PHARMA
MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	208092	P AND L
MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	No	209074	TARO
WOMEN'S ROGAINE	MINOXIDIL	5%	AEROSOL, FOAM;TOPICAL	Over-the-counter	Yes	021812	KENVUE BRANDS