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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077942
Company: APOTEX

Products on ANDA 077942

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077942

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2007	ORIG-1	Approval				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-8	Labeling-Package Insert		Label is not available on this site.
06/18/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/18/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/29/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 077942

KETOROLAC TROMETHAMINE

INJECTABLE;INJECTION; 15MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214456	ALEMBIC
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077942	APOTEX
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217166	ASPIRO
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209900	BAXTER HLTHCARE CORP
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217789	CAPLIN
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075784	FRESENIUS KABI USA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204216	GLAND
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075772	HIKMA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074802	HOSPIRA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091065	SAGENT PHARMS INC

INJECTABLE;INJECTION; 30MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214456	ALEMBIC
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077942	APOTEX
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217166	ASPIRO
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209900	BAXTER HLTHCARE CORP
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217789	CAPLIN
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075784	FRESENIUS KABI USA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203242	FRESENIUS KABI USA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204216	GLAND
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075772	HIKMA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074802	HOSPIRA
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211445	NEPHRON
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091065	SAGENT PHARMS INC
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076271	SANDOZ

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