Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208575
Company: HISUN PHARM HANGZHOU

Products on ANDA 208575

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208575Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/05/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208575

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