Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
FERRIC CARBOXYMALTOSE
ANDATentative Approval
FERRIC CARBOXYMALTOSE | A217076 | MYLAN
Products (1)
#001 — 1GM IRON/20ML (50MG IRON/ML)
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SOLUTION;INTRAVENOUS | Approved: N/A
No patent or exclusivity listings for this strength.