Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019501
Company: JOHNSON AND JOHNSON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROGAINE (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter None Yes Yes
ROGAINE (FOR WOMEN) MINOXIDIL 2% 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
08/17/1988 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2016 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/27/2015 SUPPL-29 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019501Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019501Orig1s029ltr.pdf
06/21/2005 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019501s020,025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019501s025.pdf
06/25/2004 SUPPL-24 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19501scs024ltr.pdf
06/21/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019501s020,025ltr.pdf
04/16/1998 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1994 SUPPL-13 Labeling

Label is not available on this site.

02/09/1996 SUPPL-12 Efficacy-Rx To OTC Switch

Label is not available on this site.

07/28/1993 SUPPL-11 Labeling

Label is not available on this site.

07/28/1993 SUPPL-10 Labeling

Label is not available on this site.

09/24/1992 SUPPL-9 Labeling

Label is not available on this site.

04/08/1994 SUPPL-8 Labeling

Label is not available on this site.

10/05/1990 SUPPL-7 Labeling

Label is not available on this site.

02/23/1990 SUPPL-6 Labeling

Label is not available on this site.

02/12/1990 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1990 SUPPL-4 Labeling

Label is not available on this site.

08/13/1991 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

09/19/1989 SUPPL-2 Labeling

Label is not available on this site.

08/24/1988 SUPPL-1 Labeling

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-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019501Orig1s029lbl.pdf
06/21/2005 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf
06/21/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019501s020,025lbl.pdf

ROGAINE (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; 2%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074588 ACTAVIS MID ATLANTIC
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074731 HI TECH PHARMA
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 075357 L PERRIGO CO
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074767 WOCKHARDT BIO AG
MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074731 HI TECH PHARMA
MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 075357 L PERRIGO CO
ROGAINE (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter Yes 019501 JOHNSON AND JOHNSON
ROGAINE (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter Yes 019501 JOHNSON AND JOHNSON
THEROXIDIL MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 078176 EI INC

ROGAINE (FOR WOMEN)

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

SOLUTION;TOPICAL; 2%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074588 ACTAVIS MID ATLANTIC
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074731 HI TECH PHARMA
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 075357 L PERRIGO CO
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074767 WOCKHARDT BIO AG
MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074731 HI TECH PHARMA
MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 075357 L PERRIGO CO
ROGAINE (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter Yes 019501 JOHNSON AND JOHNSON
ROGAINE (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter Yes 019501 JOHNSON AND JOHNSON
THEROXIDIL MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 078176 EI INC

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