Details for New Drug Application (NDA): 209048

NDA 209048 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 209048

Tradename:	ASPIRIN AND DIPYRIDAMOLE
Applicant:	Dr Reddys
Ingredient:	aspirin; dipyridamole
Patents:	0

Pharmacology for NDA: 209048

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

Suppliers and Packaging for NDA: 209048

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	209048	ANDA	NorthStar Rx LLC	16714-964	16714-964-01	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-964-01)
ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	209048	ANDA	Dr. Reddy's Laboratories Inc	43598-339	43598-339-60	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-339-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	25MG;200MG
Approval Date:	Oct 10, 2018	TE:	AB	RLD:	No

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