Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021528
Company: ABBVIE

Products on NDA 21528

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACULAR LS	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	No

Labels for NDA 021528

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021528s008lbl.pdf
05/25/2016	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021528s007lbl.pdf
05/30/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21528_acular_lbl.pdf