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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216651
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET;ORAL Prescription AB 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
08/25/2022 ORIG-1 Approval STANDARD

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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