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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022427
Company: ABBVIE

Summary Review

Products on NDA 022427

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022427

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

Labels for NDA 022427

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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