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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 086944

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NDA 086944 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 are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dipyridamole profile page.

Summary for 086944

Tradename:	DIPYRIDAMOLE
Applicant:	Ani Pharms
Ingredient:	dipyridamole
Patents:	0

Medical Subject Heading (MeSH) Categories for 086944

Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 25, 1992	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Apr 16, 1991	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Feb 25, 1992	TE:		RLD:	No

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