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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208697
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription AB No No
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription AB No No
DEFERASIROX DEFERASIROX 360MG TABLET;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
12/13/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208697Orig1s000ltr.pdf

DEFERASIROX

TABLET;ORAL; 90MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 208697 ACTAVIS ELIZABETH
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 211824 ALEMBIC PHARMS
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 210555 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 214341 ANNORA PHARMA
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 212669 CELLTRION
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 211852 CIPLA
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 210945 MSN
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 212995 PIRAMAL HLTHCARE UK
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 211641 SUN PHARM
DEFERASIROX DEFERASIROX 90MG TABLET;ORAL Prescription No AB 211383 ZYDUS PHARMS
JADENU DEFERASIROX 90MG TABLET;ORAL Prescription Yes AB 206910 NOVARTIS PHARMS CORP

TABLET;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 208697 ACTAVIS ELIZABETH
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 211824 ALEMBIC PHARMS
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 210555 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 214341 ANNORA PHARMA
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 212669 CELLTRION
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 211852 CIPLA
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 210945 MSN
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 212995 PIRAMAL HLTHCARE UK
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 211641 SUN PHARM
DEFERASIROX DEFERASIROX 180MG TABLET;ORAL Prescription No AB 211383 ZYDUS PHARMS
JADENU DEFERASIROX 180MG TABLET;ORAL Prescription Yes AB 206910 NOVARTIS PHARMS CORP

TABLET;ORAL; 360MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 208697 ACTAVIS ELIZABETH
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 211824 ALEMBIC PHARMS
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 210555 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 214341 ANNORA PHARMA
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 212669 CELLTRION
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 211852 CIPLA
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 210945 MSN
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 212995 PIRAMAL HLTHCARE UK
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 211641 SUN PHARM
DEFERASIROX DEFERASIROX 360MG TABLET;ORAL Prescription No AB 211383 ZYDUS PHARMS
JADENU DEFERASIROX 360MG TABLET;ORAL Prescription Yes AB 206910 NOVARTIS PHARMS CORP
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