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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019700
Company: ABBVIE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACULAR KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/18/2025 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019700s033lbl.pdf
06/14/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019700s028lbl.pdf
03/10/2005 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf
03/10/2005 SUPPL-23 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf
02/08/2002 SUPPL-19 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19700s019lbl.pdf
07/16/2001 SUPPL-18 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19700s18lbl.pdf
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