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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075626
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE;INJECTION Discontinued 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
07/24/2001 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
04/28/2021 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

10/20/2004 SUPPL-5 Labeling

Label is not available on this site.

11/20/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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