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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074754
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription AB 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
05/16/1997 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/74754_Ketorolac.cfm
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.

05/09/2016 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/20/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

06/19/2007 SUPPL-10 Labeling

Label is not available on this site.

02/06/2007 SUPPL-9 Labeling

Label is not available on this site.

08/30/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

12/01/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/09/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

KETOROLAC TROMETHAMINE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription No AB 216407 ATNAHS PHARMA US
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription No AB 210616 CYCLE PHARMS LTD
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription No AB 216651 HETERO LABS LTD III
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription No AB 074761 MYLAN
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription No AB 215788 SENORES PHARMS
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription No AB 074754 TEVA
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription No AB 217038 ZYDUS
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