Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022427
Company: ALLERGAN
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/22/2009 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022427s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022427s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022427_acuvail_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022427s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022427s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022427Orig1s005ltr.pdf
11/16/2012 SUPPL-4 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022427Orig1s004ltr.pdf
11/15/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022427Orig1s003ltr.pdf
06/28/2010 SUPPL-1 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022427s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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