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Abbreviated New Drug Application (ANDA): 208575
Company: HISUN PHARM HANGZHOU
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TICAGRELOR TICAGRELOR 90MG 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
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.

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 208575 HISUN PHARM HANGZHOU
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