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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 208567

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NDA 208567 describes TICAGRELOR, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal, Apotex, Changzhou Pharm, Dr Reddys, Hisun Pharm Hangzhou, Invagen Pharms, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sciegen Pharms Inc, Sunshine, Taro, and Watson Labs Inc, and is included in seventeen NDAs. It is available from twenty-three suppliers. Additional details are available on the TICAGRELOR profile page.

The generic ingredient in TICAGRELOR is ticagrelor. There are twenty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.

Summary for 208567

Tradename:	TICAGRELOR
Applicant:	Alkem Labs Ltd
Ingredient:	ticagrelor
Patents:	0

Pharmacology for NDA: 208567

Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Suppliers and Packaging for NDA: 208567

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TICAGRELOR	ticagrelor	TABLET;ORAL	208567	ANDA	Ascend Laboratories, LLC	67877-491	67877-491-60	60 TABLET in 1 BOTTLE (67877-491-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Apr 21, 2023	TE:	AB	RLD:	No

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