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Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 202103

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202103

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
08/28/2025	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/28/2025	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 202103

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	216261	ALEMBIC
DASATINIB	DASATINIB	20MG	TABLET;ORAL	Prescription	No	AB	202103	APOTEX
DASATINIB	DASATINIB	20MG	TABLET;ORAL	Prescription	No	AB	217217	BIOCON PHARMA
DASATINIB	DASATINIB	20MG	TABLET;ORAL	Prescription	No	AB	213383	DR REDDYS
DASATINIB	DASATINIB	20MG	TABLET;ORAL	Prescription	No	AB	216547	EUGIA PHARMA
DASATINIB	DASATINIB	20MG	TABLET;ORAL	Prescription	No	AB	214350	LUPIN
DASATINIB	DASATINIB	20MG	TABLET;ORAL	Prescription	No	AB	211094	TEVA PHARMS USA
DASATINIB	DASATINIB	20MG	TABLET;ORAL	Prescription	No	AB	218719	ZYDUS PHARMS
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	216261	ALEMBIC
DASATINIB	DASATINIB	50MG	TABLET;ORAL	Prescription	No	AB	202103	APOTEX
DASATINIB	DASATINIB	50MG	TABLET;ORAL	Prescription	No	AB	217217	BIOCON PHARMA
DASATINIB	DASATINIB	50MG	TABLET;ORAL	Prescription	No	AB	213383	DR REDDYS
DASATINIB	DASATINIB	50MG	TABLET;ORAL	Prescription	No	AB	216547	EUGIA PHARMA
DASATINIB	DASATINIB	50MG	TABLET;ORAL	Prescription	No	AB	214350	LUPIN
DASATINIB	DASATINIB	50MG	TABLET;ORAL	Prescription	No	AB	211094	TEVA PHARMS USA
DASATINIB	DASATINIB	50MG	TABLET;ORAL	Prescription	No	AB	218719	ZYDUS PHARMS
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	216261	ALEMBIC
DASATINIB	DASATINIB	70MG	TABLET;ORAL	Prescription	No	AB	202103	APOTEX
DASATINIB	DASATINIB	70MG	TABLET;ORAL	Prescription	No	AB	217217	BIOCON PHARMA
DASATINIB	DASATINIB	70MG	TABLET;ORAL	Prescription	No	AB	213383	DR REDDYS
DASATINIB	DASATINIB	70MG	TABLET;ORAL	Prescription	No	AB	216547	EUGIA PHARMA
DASATINIB	DASATINIB	70MG	TABLET;ORAL	Prescription	No	AB	214350	LUPIN
DASATINIB	DASATINIB	70MG	TABLET;ORAL	Prescription	No	AB	211094	TEVA PHARMS USA
DASATINIB	DASATINIB	70MG	TABLET;ORAL	Prescription	No	AB	218719	ZYDUS PHARMS
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	216261	ALEMBIC
DASATINIB	DASATINIB	100MG	TABLET;ORAL	Prescription	No	AB	202103	APOTEX
DASATINIB	DASATINIB	100MG	TABLET;ORAL	Prescription	No	AB	217217	BIOCON PHARMA
DASATINIB	DASATINIB	100MG	TABLET;ORAL	Prescription	No	AB	213383	DR REDDYS
DASATINIB	DASATINIB	100MG	TABLET;ORAL	Prescription	No	AB	216547	EUGIA PHARMA
DASATINIB	DASATINIB	100MG	TABLET;ORAL	Prescription	No	AB	214350	LUPIN
DASATINIB	DASATINIB	100MG	TABLET;ORAL	Prescription	No	AB	211094	TEVA PHARMS USA
DASATINIB	DASATINIB	100MG	TABLET;ORAL	Prescription	No	AB	218719	ZYDUS PHARMS
SPRYCEL	DASATINIB	100MG	TABLET;ORAL	Prescription	Yes	AB	021986	BRISTOL MYERS SQUIBB

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