APPLICATION
ANDA074588
TYPE
ANDA
ORIGINAL APPROVAL
1996-04-05
LATEST ACTION
2015-03-13
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter
Products
MINOXIDIL (FOR MEN)Over-the-counter
MINOXIDIL 2% · SOLUTION · TOPICAL
Approval history
2015-03-13Labeling · Supplement 33AP
2005-06-15Labeling · Supplement 22AP
2005-05-17Labeling · Supplement 19AP
2005-04-14Labeling · Supplement 15AP
2005-04-14Labeling · Supplement 16AP
2002-10-04Manufacturing (CMC) · Supplement 11AP
2001-08-27Labeling · Supplement 10AP
2001-08-27Manufacturing (CMC) · Supplement 9AP
1997-07-29Manufacturing (CMC) · Supplement 6AP
1997-07-29Manufacturing (CMC) · Supplement 7AP
1997-07-29Labeling · Supplement 5AP
1997-04-07Manufacturing (CMC) · Supplement 2AP
1997-04-07Labeling · Supplement 3AP
1997-02-24Manufacturing (CMC) · Supplement 4AP
1996-04-05OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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