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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 040898

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NDA 040898 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 seven suppliers. Additional details are available on the DIPYRIDAMOLE profile page.

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

Summary for 040898

Tradename:	DIPYRIDAMOLE
Applicant:	Chartwell Rx
Ingredient:	dipyridamole
Patents:	0

Medical Subject Heading (MeSH) Categories for 040898

Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Apr 23, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 23, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Apr 23, 2008	TE:		RLD:	No

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