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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202103
Company: APOTEX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription AB No No
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription AB No No
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription AB No No
DASATINIB DASATINIB 100MG 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
06/10/2016 ORIG-1 Approval Not Applicable Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/202103Orig1s000BioeqR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2024 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
01/03/2022 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
01/03/2022 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
01/03/2022 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
01/03/2022 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
01/03/2022 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
01/03/2022 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

DASATINIB

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription No AB 202103 APOTEX
SPRYCEL DASATINIB 20MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription No AB 202103 APOTEX
SPRYCEL DASATINIB 50MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 70MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription No AB 202103 APOTEX
SPRYCEL DASATINIB 70MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 100MG TABLET;ORAL Prescription No AB 202103 APOTEX
SPRYCEL DASATINIB 100MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB
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