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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 210318


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NDA 210318 describes ASPIRIN AND DIPYRIDAMOLE, which is a drug marketed by Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Glenmark Speclt, Micro Labs, Ph Health, Sandoz, Sun Pharm, and Zydus Pharms, and is included in eleven NDAs. It is available from nine 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. Nine 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 Speclt
Ingredient:aspirin; dipyridamole
Patents:0
Pharmacology for NDA: 210318
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased 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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength25MG;200MG
Approval Date:May 24, 2019TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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