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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022427
Company: ABBVIE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACUVAIL KETOROLAC TROMETHAMINE 0.45% SOLUTION/DROPS;OPHTHALMIC Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/24/2024 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022427Orig1s007lbl.pdf
12/04/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022427s005lbl.pdf
11/16/2012 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s004lbl.pdf
11/15/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s003lbl.pdf
07/22/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022427s000lbl.pdf
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