Details for New Drug Application (NDA): 017534
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NDA 017534 describes FIORINAL, which is a drug marketed by Allergan and is included in two NDAs. Additional details are available on the FIORINAL profile page.
The generic ingredient in FIORINAL is aspirin; butalbital; caffeine; codeine phosphate. 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; codeine phosphate profile page.
The generic ingredient in FIORINAL is aspirin; butalbital; caffeine; codeine phosphate. 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; codeine phosphate profile page.
Summary for 017534
| Tradename: | FIORINAL |
| Applicant: | Allergan |
| Ingredient: | aspirin; butalbital; caffeine |
| Patents: | 0 |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 16, 1986 | TE: | RLD: | Yes | |||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 16, 1986 | TE: | RLD: | Yes | |||||
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