Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203560
Company: ACTAVIS ELIZABETH
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
01/26/2016 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203560Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203560Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/26/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203560Orig1s000lbl.pdf

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
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
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
EXJADE DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 021882 NOVARTIS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English