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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020834
Company: KENVUE BRANDS

Products on NDA 020834

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROGAINE EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020834

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020834_rogaine_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/2026	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020ltr.pdf
04/27/2015	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020834Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020834Orig1s014ltr.pdf
09/12/2006	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020834s011ltr.pdf
05/31/2005	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020834s009ltr.pdf
06/25/2004	SUPPL-7	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20834scs007ltr.pdf
02/14/2003	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020834s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20834slr003ltr.pdf
04/16/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020834

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/2026	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf
01/14/2026	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf
04/27/2015	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020834Orig1s014lbl.pdf
02/14/2003	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020834s003lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

ROGAINE EXTRA STRENGTH (FOR MEN)

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

SOLUTION;TOPICAL; 5%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	075438	AUROBINDO PHARMA LTD
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	075518	P AND L
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	075598	PERRIGO
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	217998	TARO
ROGAINE EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	Yes	020834	KENVUE BRANDS
THEROXIDIL	MINOXIDIL	5%	SOLUTION;TOPICAL	Over-the-counter	No	076239	PURE SOURCE

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