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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 075316

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NDA 075316 describes TICLOPIDINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Apotex, Chartwell Rx, Mylan, Natco Pharma, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in nine NDAs. Additional details are available on the TICLOPIDINE HYDROCHLORIDE profile page.

The generic ingredient in TICLOPIDINE HYDROCHLORIDE is ticlopidine hydrochloride. There are nine drug master file entries for this compound. Additional details are available on the ticlopidine hydrochloride profile page.

Summary for 075316

Tradename:	TICLOPIDINE HYDROCHLORIDE
Applicant:	Natco Pharma
Ingredient:	ticlopidine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 075316

Cytochrome P-450 CYP2C19 Inhibitors
Fibrinolytic Agents
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Nov 2, 1999	TE:		RLD:	No

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