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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075299
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE;INJECTION Discontinued None No No
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
11/03/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75229ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/12/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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