An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208597
Company: MYLAN

Products on ANDA 208597

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 208597

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2025	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/04/2025	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/05/2024	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/05/2024	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208597

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
TICAGRELOR	TICAGRELOR	60MG	TABLET;ORAL	Prescription	No	AB	219006	ZHEJIANG JINGXIN

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
TICAGRELOR	TICAGRELOR	90MG	TABLET;ORAL	Prescription	No	AB	219006	ZHEJIANG JINGXIN

Top