Details for New Drug Application (NDA): 205230
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NDA 205230 describes BUTALBITAL, ASPIRIN AND CAFFEINE, which is a drug marketed by Lgm Pharma, Nostrum Labs Inc, Watson Labs, Actavis Elizabeth, Fosun Pharma, Halsey, Hikma Intl Pharms, Ivax Pharms, Puracap Pharm, Quantum Pharmics, and Strides Pharma, and is included in twelve NDAs. It is available from two suppliers. Additional details are available on the BUTALBITAL, ASPIRIN AND CAFFEINE profile page.
The generic ingredient in BUTALBITAL, ASPIRIN AND CAFFEINE is aspirin; butalbital; caffeine. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.
The generic ingredient in BUTALBITAL, ASPIRIN AND CAFFEINE is aspirin; butalbital; caffeine. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.
Summary for 205230
| Tradename: | BUTALBITAL, ASPIRIN AND CAFFEINE |
| Applicant: | Lgm Pharma |
| Ingredient: | aspirin; butalbital; caffeine |
| Patents: | 0 |
Pharmacology for NDA: 205230
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 205230
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL, ASPIRIN AND CAFFEINE | aspirin; butalbital; caffeine | CAPSULE;ORAL | 205230 | ANDA | LGM PHARMA SOLUTIONS, LLC | 79739-7192 | 79739-7192-1 | 100 CAPSULE in 1 BOTTLE (79739-7192-1) |
| BUTALBITAL, ASPIRIN AND CAFFEINE | aspirin; butalbital; caffeine | CAPSULE;ORAL | 205230 | ANDA | LGM PHARMA SOLUTIONS, LLC | 79739-7192 | 79739-7192-5 | 500 CAPSULE in 1 BOTTLE (79739-7192-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 500MG;50MG;40MG | ||||
| Approval Date: | Oct 18, 2021 | TE: | RLD: | No | |||||
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