Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075518
Company: P AND L
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
11/17/2000 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75518ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75518ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2013 SUPPL-24 Labeling

Label is not available on this site.

05/17/2005 SUPPL-12 Labeling

Label is not available on this site.

06/15/2005 SUPPL-11 Labeling

Label is not available on this site.

04/12/2005 SUPPL-7 Labeling

Label is not available on this site.

10/04/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/2001 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/2001 SUPPL-2 Labeling

Label is not available on this site.

10/31/2001 SUPPL-1 Manufacturing (CMC)-Packaging

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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