Details for New Drug Application (NDA): 208597

NDA 208597 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 208597

Tradename:	TICAGRELOR
Applicant:	Mylan
Ingredient:	ticagrelor
Patents:	0

Pharmacology for NDA: 208597

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

Suppliers and Packaging for NDA: 208597

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TICAGRELOR	ticagrelor	TABLET;ORAL	208597	ANDA	Mylan Pharmaceuticals Inc.	0378-2214	0378-2214-91	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2214-91)
TICAGRELOR	ticagrelor	TABLET;ORAL	208597	ANDA	Mylan Pharmaceuticals Inc.	0378-2215	0378-2215-91	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2215-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Jul 9, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Jul 9, 2021	TE:	AB	RLD:	No

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