Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077308
Company: APOTEX INC

Products on ANDA 077308

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077308

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/2009/077308s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2017	SUPPL-7	Labeling-Package Insert		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 077308

KETOROLAC TROMETHAMINE

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