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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 208575

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NDA 208575 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, Mankind Pharma, MSN, Mylan, Prinston Inc, Sciegen Pharms, Sunshine, Taro, and Watson Labs Inc, and is included in eighteen NDAs. It is available from twenty-four 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-six suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.

Summary for 208575

Tradename:	TICAGRELOR
Applicant:	Hisun Pharm Hangzhou
Ingredient:	ticagrelor
Patents:	0

Pharmacology for NDA: 208575

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

Suppliers and Packaging for NDA: 208575

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TICAGRELOR	ticagrelor	TABLET;ORAL	208575	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-115	42658-115-03	60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Jan 23, 2019	TE:	AB	RLD:	No

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