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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213239
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEFERIPRONE DEFERIPRONE 500MG TABLET;ORAL Prescription AB No No
DEFERIPRONE DEFERIPRONE 1GM 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
03/29/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2022 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/21/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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

TABLET;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERIPRONE DEFERIPRONE 1GM TABLET;ORAL Prescription No AB 213239 HIKMA
FERRIPROX DEFERIPRONE 1GM TABLET;ORAL Prescription Yes AB 021825 CHIESI
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