Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020834
Company: JOHNSON AND JOHNSON
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
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 075518 ACTAVIS MID ATLANTIC
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 075619 AVACOR PRODS
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 075737 PERRIGO NEW YORK
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 075438 WOCKHARDT BIO AG
ROGAINE EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter Yes 020834 JOHNSON AND JOHNSON
THEROXIDIL MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 076239 EI INC

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