APPLICATION
ANDA074881
TYPE
ANDA
ORIGINAL APPROVAL
2000-07-28
LATEST ACTION
2001-08-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
IOPAMIDOL-370Discontinued
IOPAMIDOL 76% · INJECTABLE · INJECTION
IOPAMIDOL-250Discontinued
IOPAMIDOL 51% · INJECTABLE · INJECTION
IOPAMIDOL-300Discontinued
IOPAMIDOL 61% · INJECTABLE · INJECTION
IOPAMIDOL-200Discontinued
IOPAMIDOL 41% · INJECTABLE · INJECTION
Approval history
2001-08-17Manufacturing (CMC) · Supplement 5AP
2001-03-20Manufacturing (CMC) · Supplement 4AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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