Details for New Drug Application (NDA): 206392
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NDA 206392 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.
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 206392
| Tradename: | ASPIRIN AND DIPYRIDAMOLE |
| Applicant: | Amneal Pharms |
| Ingredient: | aspirin; dipyridamole |
| Patents: | 0 |
Pharmacology for NDA: 206392
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 206392
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 206392 | ANDA | AvKARE | 42291-116 | 42291-116-60 | 60 CAPSULE in 1 BOTTLE (42291-116-60) |
| ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 206392 | ANDA | Amneal Pharmaceuticals LLC | 65162-596 | 65162-596-06 | 60 CAPSULE in 1 BOTTLE (65162-596-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 25MG;200MG | ||||
| Approval Date: | Mar 8, 2016 | TE: | AB | RLD: | No | ||||
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