Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074993
Company: HOSPIRA

Products on ANDA 074993

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074993

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74993ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2024	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
11/21/2022	SUPPL-48	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
05/20/2016	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
05/29/2013	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/30/2012	SUPPL-16	Labeling		Label is not available on this site.
03/14/2003	SUPPL-6	Labeling		Label is not available on this site.
07/03/2002	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
02/14/2001	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/04/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/04/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 074993

KETOROLAC TROMETHAMINE

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