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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217679
Company: MANKIND PHARMA

Products on ANDA 217679

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	AB	No	No
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217679

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/06/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217679Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217679

TICAGRELOR

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRILINTA	TICAGRELOR	60MG	TABLET;ORAL	Prescription	Yes	AB	022433	ASTRAZENECA
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208576	ALEMBIC
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	210219	ALKEM LABS LTD
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208531	AMNEAL
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208584	APOTEX
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	216187	CHANGZHOU PHARM
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208541	DR REDDYS
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208537	INVAGEN PHARMS
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	212258	MACLEODS PHARMS LTD
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	217679	MANKIND PHARMA
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208596	MSN
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208597	MYLAN
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	218962	SCIEGEN PHARMS
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208508	SUNSHINE
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	211498	TARO
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	208390	WATSON LABS INC

TABLET;ORAL; 90MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRILINTA	TICAGRELOR	90MG	TABLET;ORAL	Prescription	Yes	AB	022433	ASTRAZENECA
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208576	ALEMBIC
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208567	ALKEM LABS LTD
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208584	APOTEX
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	216187	CHANGZHOU PHARM
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208541	DR REDDYS
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208575	HISUN PHARM HANGZHOU
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208537	INVAGEN PHARMS
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	212258	MACLEODS PHARMS LTD
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	217679	MANKIND PHARMA
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208596	MSN
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208597	MYLAN
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208599	PRINSTON INC
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	218962	SCIEGEN PHARMS
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208508	SUNSHINE
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	211498	TARO
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208390	WATSON LABS INC

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