Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076209
Company: AMPHASTAR PHARM
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
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 60MG/2ML INJECTABLE; INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/21/2004 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
05/10/2016 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

05/09/2016 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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 076209 AMPHASTAR PHARM
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 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 PHARMA LTD
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE;INJECTION Prescription No AP 074802 HOSPIRA
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE;INJECTION Prescription No AP 074993 HOSPIRA
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE;INJECTION Prescription No AP 091065 SAGENT PHARMS
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE;INJECTION Prescription No AP 075772 WEST-WARD PHARMS INT
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 076209 AMPHASTAR PHARM
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 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 PHARMA LTD
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 091065 SAGENT PHARMS
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE;INJECTION Prescription No AP 076271 SANDOZ INC
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE;INJECTION Prescription No AP 075772 WEST-WARD PHARMS INT
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE;INJECTION Prescription No AP 077942 WOCKHARDT

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