Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021812
Company: JOHNSON AND JOHNSON
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/20/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021812s000LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021812s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021812s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/10/2015 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021812Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021812Orig1s011ltr.pdf
12/13/2013 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021812Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021812Orig1s010ltr.pdf
02/28/2014 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021812Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021812Orig1s009ltr.pdf
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.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021812s001LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/10/2015 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021812Orig1s011lbl.pdf
02/28/2014 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021812Orig1s009lbl.pdf
12/13/2013 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021812Orig1s010lbl.pdf
01/20/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021812s000LBL.pdf

MEN'S ROGAINE

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

AEROSOL, FOAM;TOPICAL; 5%
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 JOHNSON AND JOHNSON
MINOXIDIL MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 091344 PERRIGO ISRAEL
MINOXIDIL (FOR MEN) MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 208092 WATSON LABS INC
MINOXIDIL (FOR WOMEN) MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 208092 WATSON LABS INC
WOMEN'S ROGAINE MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter Yes 021812 JOHNSON AND JOHNSON

WOMEN'S ROGAINE

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

AEROSOL, FOAM;TOPICAL; 5%
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 JOHNSON AND JOHNSON
MINOXIDIL MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 091344 PERRIGO ISRAEL
MINOXIDIL (FOR MEN) MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 208092 WATSON LABS INC
MINOXIDIL (FOR WOMEN) MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 208092 WATSON LABS INC
WOMEN'S ROGAINE MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter Yes 021812 JOHNSON AND JOHNSON

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