Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075357
Company: L PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter None No No
MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/30/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75357ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/1999/075357Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/30/2016 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.

10/08/2008 SUPPL-14 Labeling

Label is not available on this site.

07/14/2005 SUPPL-5 Labeling

Label is not available on this site.

MINOXIDIL (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

MINOXIDIL (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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