Details for New Drug Application (NDA): 210318
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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 Speclt |
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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