Details for New Drug Application (NDA): 086996
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NDA 086996 describes LANORINAL, which is a drug marketed by Sandoz and Lannett and is included in two NDAs. It is available from three suppliers. Additional details are available on the LANORINAL profile page.
The generic ingredient in LANORINAL 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 LANORINAL 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 086996
| Tradename: | LANORINAL |
| Applicant: | Sandoz |
| Ingredient: | aspirin; butalbital; caffeine |
| Patents: | 0 |
Pharmacology for NDA: 086996
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 086996
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LANORINAL | aspirin; butalbital; caffeine | CAPSULE;ORAL | 086996 | ANDA | Lannett Company, Inc. | 0527-1552 | 0527-1552-01 | 100 CAPSULE in 1 BOTTLE (0527-1552-01) |
| LANORINAL | aspirin; butalbital; caffeine | CAPSULE;ORAL | 086996 | ANDA | Sandoz Inc | 0781-2270 | 0781-2270-01 | 100 CAPSULE in 1 BOTTLE (0781-2270-01) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG | ||||
| Approval Date: | Oct 11, 1985 | TE: | AA | RLD: | No | ||||
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