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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021528
Company: ABBVIE

Products on NDA 021528

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021528

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21528_acular_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21528ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21528_Acular.cfm

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021528s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021528Orig1s008ltr.pdf
05/25/2016	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021528s007lbl.pdf
12/01/2008	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021528s005ltr.pdf

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

Therapeutic Equivalents for NDA 021528

ACULAR LS

SOLUTION/DROPS;OPHTHALMIC; 0.4%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACULAR LS	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	021528	ABBVIE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	077308	APOTEX INC

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