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Abbreviated New Drug Application (ANDA): 209577
Company: SUN PHARM INDUSTRIES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BOSUTINIB BOSUTINIB MONOHYDRATE 400MG TABLET;FILM COATED None (Tentative Approval) None No No
BOSUTINIB BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET;FILM COATED None (Tentative Approval) None No No
BOSUTINIB BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET;FILM COATED 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
08/25/2023 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209577Orig1s000TA_ltr.pdf
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