Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210920
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription AB No No
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription AB No No
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL 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
11/20/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

DEFERASIROX

TABLET, FOR SUSPENSION;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 203560 ACTAVIS ELIZABETH
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210060 ALEMBIC PHARMS LTD
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210519 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210920 BIONPHARMA INC
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209433 ICHNOS
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209878 MSN
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209782 SUN PHARM
EXJADE DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 021882 NOVARTIS

TABLET, FOR SUSPENSION;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 203560 ACTAVIS ELIZABETH
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210060 ALEMBIC PHARMS LTD
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210519 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210920 BIONPHARMA INC
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209433 ICHNOS
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209878 MSN
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209782 SUN PHARM
EXJADE DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 021882 NOVARTIS

TABLET, FOR SUSPENSION;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 203560 ACTAVIS ELIZABETH
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210060 ALEMBIC PHARMS LTD
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210519 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 210920 BIONPHARMA INC
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209433 ICHNOS
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209878 MSN
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 209782 SUN PHARM
EXJADE DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 021882 NOVARTIS

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