Details for New Drug Application (NDA): 207944

NDA 207944 describes ASPIRIN AND DIPYRIDAMOLE, which is a drug marketed by Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Endo Operations, Glenmark Speclt, Micro Labs, Sandoz, Sun Pharm, and Zydus Pharms, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the ASPIRIN AND DIPYRIDAMOLE profile page.

The generic ingredient in ASPIRIN AND DIPYRIDAMOLE is aspirin; dipyridamole. There are twenty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the aspirin; dipyridamole profile page.

Summary for 207944

Tradename:	ASPIRIN AND DIPYRIDAMOLE
Applicant:	Endo Operations
Ingredient:	aspirin; dipyridamole
Patents:	0

Pharmacology for NDA: 207944

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Platelet Aggregation Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 207944

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	207944	ANDA	Major Pharmaceuticals	0904-7056	0904-7056-99	20 BLISTER PACK in 1 CARTON (0904-7056-99) / 1 CAPSULE in 1 BLISTER PACK
ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	207944	ANDA	Endo USA, Inc.	49884-007	49884-007-02	60 CAPSULE in 1 BOTTLE (49884-007-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	25MG;200MG
Approval Date:	Jan 18, 2017	TE:	AB	RLD:	No

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