Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210616
Company: CHARTWELL RX

Products on ANDA 210616

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210616

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/16/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 210616

KETOROLAC TROMETHAMINE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	No	AB	216759	BIONPHARMA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	No	AB	210616	CHARTWELL RX
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	No	AB	216651	HETERO LABS LTD III
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	No	AB	215745	LEADING
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	No	AB	074761	MYLAN
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	No	AB	215788	SENORES PHARMS
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	No	AB	074754	TEVA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET;ORAL	Prescription	No	AB	217038	ZYDUS LIFESCIENCES