APPLICATION
ANDA072709
TYPE
ANDA
ORIGINAL APPROVAL
1995-12-13
LATEST ACTION
2018-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MINOXIDILPrescription
MINOXIDIL 2.5MG · TABLET · ORAL
MINOXIDILPrescription
MINOXIDIL 10MG · TABLET · ORAL
Approval history
2018-05-15Labeling · Supplement 25 · standardAP
2004-06-16Labeling · Supplement 11AP
2002-06-06Manufacturing (CMC) · Supplement 6AP
2000-05-16Manufacturing (CMC) · Supplement 5AP
2000-05-16Manufacturing (CMC) · Supplement 4AP
1997-12-05Manufacturing (CMC) · Supplement 3AP
1997-02-24Manufacturing (CMC) · Supplement 2AP
1996-05-28Manufacturing (CMC) · Supplement 1AP
1995-12-13OriginalAP
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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