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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208977
Company: INTL MEDICATION SYS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IRON SUCROSE IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription AB No No
IRON SUCROSE IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription AB No No
IRON SUCROSE IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription AB 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
08/08/2025 ORIG-1 Approval STANDARD

Label is not available on this site.

IRON SUCROSE

INJECTABLE;INTRAVENOUS; EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IRON SUCROSE IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 208977 INTL MEDICATION SYS
IRON SUCROSE IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 212559 MYLAN LABS LTD
IRON SUCROSE IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 212340 SANDOZ
VENOFER IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription Yes AB 021135 AM REGENT

INJECTABLE;INTRAVENOUS; EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IRON SUCROSE IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 208977 INTL MEDICATION SYS
IRON SUCROSE IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 212559 MYLAN LABS LTD
IRON SUCROSE IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 212340 SANDOZ
VENOFER IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription Yes AB 021135 AM REGENT

INJECTABLE;INTRAVENOUS; EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IRON SUCROSE IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 208977 INTL MEDICATION SYS
IRON SUCROSE IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 212559 MYLAN LABS LTD
IRON SUCROSE IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription No AB 212340 SANDOZ
VENOFER IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE;INTRAVENOUS Prescription Yes AB 021135 AM REGENT
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