← FDA DRUG APPROVALS

FDA ANDA · ANDA075839

MINOXIDIL EXTRA STRENGTH (FOR MEN)

Sponsor: APOTEX INC

APPLICATION
ANDA075839
TYPE
ANDA
ORIGINAL APPROVAL
2001-10-01
LATEST ACTION
2007-03-15
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

MINOXIDIL EXTRA STRENGTH (FOR MEN)Discontinued
MINOXIDIL 5% · SOLUTION · TOPICAL

Approval history

2007-03-15Labeling · Supplement 13AP
2005-04-12Labeling · Supplement 8AP
2003-08-29Labeling · Supplement 6AP
2002-12-09Manufacturing (CMC) · Supplement 4AP
2002-02-15Manufacturing (CMC) · Supplement 2AP
2002-02-15Manufacturing (CMC) · Supplement 1AP
2001-10-01Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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