Details for New Drug Application (NDA): 210318

NDA 210318 describes ASPIRIN AND DIPYRIDAMOLE, which is a drug marketed by Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Glenmark Pharms Sa, Micro Labs, Par Pharm Inc, 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 210318

Tradename:	ASPIRIN AND DIPYRIDAMOLE
Applicant:	Glenmark Pharms Sa
Ingredient:	aspirin; dipyridamole
Patents:	0

Pharmacology for NDA: 210318

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

Suppliers and Packaging for NDA: 210318

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	210318	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-405	68462-405-30	30 CAPSULE in 1 BOTTLE (68462-405-30)
ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	210318	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-405	68462-405-60	60 CAPSULE in 1 BOTTLE (68462-405-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	25MG;200MG
Approval Date:	May 24, 2019	TE:	AB	RLD:	No

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