Last Updated: November 8, 2026

Details for New Drug Application (NDA): 075769

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NDA 075769 describes DIPYRIDAMOLE, which is a drug marketed by Chartwell Injectable, Dr Reddys, Eugia Pharma Speclts, Fresenius Kabi Usa, Hikma, Hospira, Ani Pharms, Barr, Barr Labs, Chartwell Rx, Glenmark Generics, Impax Labs, Oxford Pharms, Purepac Pharm, Rising, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. It is available from eight suppliers. Additional details are available on the DIPYRIDAMOLE profile page.

The generic ingredient in DIPYRIDAMOLE is dipyridamole. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the dipyridamole profile page.

Summary for 075769

Tradename:	DIPYRIDAMOLE
Applicant:	Eugia Pharma Speclts
Ingredient:	dipyridamole
Patents:	0

Medical Subject Heading (MeSH) Categories for 075769

Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML
Approval Date:	Nov 27, 2002	TE:		RLD:	No

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