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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075784
Company: FRESENIUS KABI USA

Products on ANDA 075784

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 075784

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2002	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
04/28/2021	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/11/2016	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/11/2002	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075784

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	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	203242	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
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078737	SUN PHARM
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077942	WOCKHARDT

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	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	074993	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
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078737	SUN PHARM
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077942	WOCKHARDT

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