U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212559
Company: MYLAN LABS LTD

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
Back to Top