Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208599
Company: PRINSTON INC

Products on ANDA 208599

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	AB	No	No
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208599

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/16/2024	ORIG-2	Tentative Approval		STANDARD		Label is not available on this site.
08/16/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208599Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 208599

TICAGRELOR

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	208567	ALKEM LABS LTD
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208575	HISUN PHARM HANGZHOU
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	208599	PRINSTON INC