Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075839
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Discontinued 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
10/01/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-839_Minoxidil.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-839_Minoxidil.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2007 SUPPL-13 Labeling

Label is not available on this site.

04/12/2005 SUPPL-8 Labeling

Label is not available on this site.

08/29/2003 SUPPL-6 Labeling

Label is not available on this site.

12/09/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

02/15/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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