Details for New Drug Application (NDA): 074951
✉ Email this page to a colleague
NDA 074951 describes BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, which is a drug marketed by Dr Reddys Labs Sa, Esjay Pharma, Lgm Pharma, Stevens J, and Watson Labs, and is included in five NDAs. It is available from five suppliers. Additional details are available on the BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE profile page.
The generic ingredient in BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE is aspirin; butalbital; caffeine; codeine phosphate. 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; codeine phosphate profile page.
The generic ingredient in BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE is aspirin; butalbital; caffeine; codeine phosphate. 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; codeine phosphate profile page.
Summary for 074951
| Tradename: | BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE |
| Applicant: | Stevens J |
| Ingredient: | aspirin; butalbital; caffeine; codeine phosphate |
| Patents: | 0 |
Pharmacology for NDA: 074951
| Mechanism of Action | Cyclooxygenase Inhibitors Full Opioid Agonists |
| Physiological Effect | Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 074951
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | aspirin; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 074951 | ANDA | Lannett Company, Inc. | 0527-1312 | 0527-1312-01 | 100 CAPSULE in 1 BOTTLE (0527-1312-01) |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | aspirin; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 074951 | ANDA | Amneal Pharmaceuticals of New York, LLC | 69238-1993 | 69238-1993-1 | 100 CAPSULE in 1 BOTTLE (69238-1993-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG;30MG | ||||
| Approval Date: | Aug 31, 1998 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
