Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075598
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% 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
06/13/2001 ORIG-1 Approval Letter (PDF)
Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75598ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75598ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075598Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2008 SUPPL-18 Labeling

Label is not available on this site.

07/14/2005 SUPPL-13 Labeling

Label is not available on this site.

08/30/2005 SUPPL-9 Labeling

Label is not available on this site.

08/09/2004 SUPPL-4 Labeling

Label is not available on this site.

MINOXIDIL 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 075619 AVACOR PRODS
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 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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