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Abbreviated New Drug Application (ANDA): 208800
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEFERIPRONE DEFERIPRONE 500MG 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
02/08/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208800Orig1s000ltr.pdf

DEFERIPRONE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERIPRONE DEFERIPRONE 500MG TABLET;ORAL Prescription No AB 213239 HIKMA
DEFERIPRONE DEFERIPRONE 500MG TABLET;ORAL Prescription No AB 208800 TARO PHARM INDS LTD
FERRIPROX DEFERIPRONE 500MG TABLET;ORAL Prescription Yes AB 021825 CHIESI
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