Details for New Drug Application (NDA): 204195
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The generic ingredient in BUTALBITAL, ASPIRIN AND CAFFEINE is aspirin; butalbital; caffeine. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.
Summary for 204195
Tradename: | BUTALBITAL, ASPIRIN AND CAFFEINE |
Applicant: | Strides Pharma |
Ingredient: | aspirin; butalbital; caffeine |
Patents: | 0 |
Pharmacology for NDA: 204195
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 204195
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ASPIRIN AND CAFFEINE | aspirin; butalbital; caffeine | TABLET;ORAL | 204195 | ANDA | Vensun Pharmaceuticals, Inc. | 42543-098 | 42543-098-01 | 100 TABLET in 1 BOTTLE, PLASTIC (42543-098-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;50MG;40MG | ||||
Approval Date: | Sep 22, 2016 | TE: | RLD: | No |
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