Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218204
Company: CAPLIN

Products on ANDA 218204

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 218204

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218204

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 INC
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
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	090017	SUN PHARM