FDA ANDA · ANDA074643

MINOXIDIL (FOR MEN)

Sponsor: BAUSCH AND LOMB

APPLICATION

ANDA074643

TYPE

ANDA

ORIGINAL APPROVAL

1996-04-09

LATEST ACTION

1999-08-11

ROUTE

TOPICAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

MINOXIDIL (FOR MEN)Discontinued

MINOXIDIL 2% · SOLUTION · TOPICAL

1999-08-11Manufacturing (CMC) · Supplement 10AP

1999-08-11Manufacturing (CMC) · Supplement 11AP

1999-08-11Manufacturing (CMC) · Supplement 12AP

1999-04-29Manufacturing (CMC) · Supplement 9AP

1998-03-27Manufacturing (CMC) · Supplement 8AP

1997-04-07Manufacturing (CMC) · Supplement 4AP

1996-10-18Manufacturing (CMC) · Supplement 2AP

1996-10-18Labeling · Supplement 1AP

1996-04-09OriginalAP

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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.