FDA NDA · NDA022427

ACUVAIL

ketorolac tromethamine

Sponsor: ABBVIE

APPLICATION

NDA022427

TYPE

NDA

ORIGINAL APPROVAL

2009-07-22

LATEST ACTION

2024-05-24

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Prescription

Products

ACUVAIL · ReferencePrescription

KETOROLAC TROMETHAMINE 0.45% · SOLUTION/DROPS · OPHTHALMIC

2024-05-24Labeling · Supplement 7 · standard — Label ↗AP

2014-12-04Labeling · Supplement 5 · standard — Letter ↗AP

2012-11-16Manufacturing (CMC) · Supplement 4 — Label ↗AP

2012-11-15Labeling · Supplement 3 · standard — Label ↗AP

2010-06-28Labeling · Supplement 1 · unknown — Letter ↗AP

2009-07-22Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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.

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