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Details for New Drug Application (NDA): 017534

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NDA 017534 describes FIORINAL, which is a drug marketed by Allergan Sales Llc and is included in two NDAs. It is available from six suppliers. Additional details are available on the FIORINAL profile page.

The generic ingredient in FIORINAL is aspirin; butalbital; caffeine; codeine phosphate. There are twenty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine; codeine phosphate profile page.

Summary for NDA: 017534

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 017534

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
aspirin; butalbital; caffeine
CAPSULE;ORAL 017534 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3219 0591-3219-01 100 CAPSULE in 1 BOTTLE (0591-3219-01)
aspirin; butalbital; caffeine
CAPSULE;ORAL 017534 NDA AUTHORIZED GENERIC STAT RX USA LLC 16590-911 16590-911-30 30 CAPSULE in 1 BOTTLE (16590-911-30)

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 16, 1986TE:RLD:Yes

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength325MG;50MG;40MG
Approval Date:Apr 16, 1986TE:AARLD:Yes

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