Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213374
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEFERASIROX DEFERASIROX 90MG GRANULE;ORAL Prescription AB No No
DEFERASIROX DEFERASIROX 180MG GRANULE;ORAL Prescription AB No No
DEFERASIROX DEFERASIROX 360MG GRANULE;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
07/14/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213374Orig1s000ltr.pdf

DEFERASIROX

GRANULE;ORAL; 90MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 90MG GRANULE;ORAL Prescription No AB 213374 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 90MG GRANULE;ORAL Prescription No AB 214194 AMNEAL
DEFERASIROX DEFERASIROX 90MG GRANULE;ORAL Prescription No AB 214559 AUCTA
DEFERASIROX DEFERASIROX 90MG GRANULE;ORAL Prescription No AB 214180 TEVA PHARMS USA
JADENU SPRINKLE DEFERASIROX 90MG GRANULE;ORAL Prescription Yes AB 207968 NOVARTIS

GRANULE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 180MG GRANULE;ORAL Prescription No AB 213374 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 180MG GRANULE;ORAL Prescription No AB 214194 AMNEAL
DEFERASIROX DEFERASIROX 180MG GRANULE;ORAL Prescription No AB 214559 AUCTA
DEFERASIROX DEFERASIROX 180MG GRANULE;ORAL Prescription No AB 214650 MSN
DEFERASIROX DEFERASIROX 180MG GRANULE;ORAL Prescription No AB 214180 TEVA PHARMS USA
JADENU SPRINKLE DEFERASIROX 180MG GRANULE;ORAL Prescription Yes AB 207968 NOVARTIS

GRANULE;ORAL; 360MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 360MG GRANULE;ORAL Prescription No AB 213374 ALKEM LABS LTD
DEFERASIROX DEFERASIROX 360MG GRANULE;ORAL Prescription No AB 214194 AMNEAL
DEFERASIROX DEFERASIROX 360MG GRANULE;ORAL Prescription No AB 214559 AUCTA
DEFERASIROX DEFERASIROX 360MG GRANULE;ORAL Prescription No AB 214650 MSN
DEFERASIROX DEFERASIROX 360MG GRANULE;ORAL Prescription No AB 214180 TEVA PHARMS USA
JADENU SPRINKLE DEFERASIROX 360MG GRANULE;ORAL Prescription Yes AB 207968 NOVARTIS

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