Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076109
Company: APOTEX

Products on ANDA 076109

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076109

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076109s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/22/2026	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/05/2018	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
12/11/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/28/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076109

KETOROLAC TROMETHAMINE

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACULAR	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	019700	ABBVIE
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076109	APOTEX
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	218204	CAPLIN
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	203410	MICRO LABS LTD INDIA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076583	SANDOZ