Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208508
Company: SUNSHINE
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
04/06/2020 ORIG-2 Tentative Approval STANDARD

Label is not available on this site.

04/06/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208508Orig1s000ltr.pdf

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 PHARMS
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208575 HISUN PHARM HANGZHOU
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208596 SIGMAPHARM LABS LLC
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208508 SUNSHINE

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