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FDA ANDA · ANDA075518
HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN
minoxidil
Sponsor: P AND L
APPLICATION
ANDA075518
TYPE
ANDA
ORIGINAL APPROVAL
2000-11-17
LATEST ACTION
2013-05-29
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter
Products
MINOXIDIL EXTRA STRENGTH (FOR MEN)Over-the-counter
MINOXIDIL 5% · SOLUTION · TOPICAL
Approval history
2013-05-29Labeling · Supplement 24AP
2005-06-15Labeling · Supplement 11AP
2005-05-17Labeling · Supplement 12AP
2005-04-12Labeling · Supplement 7AP
2002-10-04Manufacturing (CMC) · Supplement 4AP
2001-10-31Manufacturing (CMC) · Supplement 3AP
2001-10-31Manufacturing (CMC) · Supplement 1AP
2001-10-31Labeling · Supplement 2AP
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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