Details for New Drug Application (NDA): 074521

NDA 074521 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 074521

Tradename:	DIPYRIDAMOLE
Applicant:	Hikma
Ingredient:	dipyridamole
Patents:	0

Pharmacology for NDA: 074521

Physiological Effect

Decreased Platelet Aggregation

Medical Subject Heading (MeSH) Categories for 074521

Phosphodiesterase Inhibitors

Platelet Aggregation Inhibitors

Vasodilator Agents

Suppliers and Packaging for NDA: 074521

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIPYRIDAMOLE	dipyridamole	INJECTABLE;INJECTION	074521	ANDA	Henry Schein, Inc.	0404-9852	0404-9852-10	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9852-10) / 10 mL in 1 VIAL, SINGLE-DOSE
DIPYRIDAMOLE	dipyridamole	INJECTABLE;INJECTION	074521	ANDA	Hikma Pharmaceuticals USA Inc.	0641-2569	0641-2569-44	5 VIAL in 1 CARTON (0641-2569-44) / 10 mL in 1 VIAL (0641-2569-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML
Approval Date:	Oct 18, 1996	TE:	AP	RLD:	No

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