Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074679
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IOPAMIDOL-250 IOPAMIDOL 51% INJECTABLE;INJECTION Discontinued None No No
IOPAMIDOL-300 IOPAMIDOL 61% INJECTABLE;INJECTION Discontinued None No No
IOPAMIDOL-370 IOPAMIDOL 76% 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
04/02/1997 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
12/05/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

08/21/2000 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/02/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/03/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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