Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201275
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE;ORAL None (Tentative Approval) None No No
SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL None (Tentative Approval) None No No
SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE;ORAL None (Tentative Approval) None No No
SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL None (Tentative Approval) None 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
03/08/2016 ORIG-1 Tentative Approval Not Applicable Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201275Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201275Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/08/2016 ORIG-1 Tentative Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201275Orig1s000lbl.pdf

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