FDA NDA · NDA020698

MIRALAX

Sponsor: BRAINTREE

APPLICATION

NDA020698

TYPE

NDA

ORIGINAL APPROVAL

1999-02-18

LATEST ACTION

2009-03-13

ROUTE

ORAL

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Discontinued

Products

MIRALAXDiscontinued

POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL · FOR SOLUTION · ORAL

2009-03-13Efficacy · Supplement 7 · standardAP

2009-03-13Efficacy · Supplement 1 · unknownAP

2004-08-09Labeling · Supplement 9 · standard — Letter ↗AP

2004-04-05Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP

2001-06-21Manufacturing (CMC) · Supplement 5 · standardAP

2001-06-20Labeling · Supplement 3 · standardAP

2000-08-18Manufacturing (CMC) · Supplement 2 · standardAP

1999-02-18Type 3 - New Dosage Form · Original · standard — Review ↗AP

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.