APPLICATION
ANDA071344
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-03
LATEST ACTION
2024-08-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MINOXIDILPrescription
MINOXIDIL 2.5MG · TABLET · ORAL
Approval history
2024-08-09Labeling · Supplement 41 · standardAP
2020-05-19Labeling · Supplement 37 · standardAP
2003-03-24Labeling · Supplement 17AP
2001-06-08Manufacturing (CMC) · Supplement 15AP
2001-04-25Manufacturing (CMC) · Supplement 16AP
2000-07-31Manufacturing (CMC) · Supplement 14AP
1998-04-01Manufacturing (CMC) · Supplement 12AP
1996-04-17Labeling · Supplement 11AP
1993-05-13Labeling · Supplement 10AP
1991-01-28Manufacturing (CMC) · Supplement 9AP
1988-09-07Manufacturing (CMC) · Supplement 6AP
1988-09-07Labeling · Supplement 5AP
1988-07-01Labeling · Supplement 4AP
1988-03-01Labeling · Supplement 3AP
1987-08-12Manufacturing (CMC) · Supplement 1AP
1987-08-12Manufacturing (CMC) · Supplement 2AP
1987-03-03OriginalAP
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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