Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074802
Company: HOSPIRA
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 Yes
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/05/1997 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
05/09/2016 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

12/14/2014 SUPPL-38 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/074802s038lbl.pdf
05/29/2013 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

03/14/2003 SUPPL-22 Labeling

Label is not available on this site.

10/25/2002 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/29/2002 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

12/16/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/17/2001 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/04/2002 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/14/2001 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/06/2001 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/22/2001 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/23/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1999 SUPPL-9 Labeling

Label is not available on this site.

12/10/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1999 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/10/1999 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

01/07/2000 SUPPL-4 Labeling

Label is not available on this site.

01/07/2000 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/08/1997 SUPPL-2 Labeling

Label is not available on this site.

06/12/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/14/2014 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/074802s038lbl.pdf

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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