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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
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Generated: July 25, 2017

DrugPatentWatch Database Preview

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 four 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Harvard Business School
US Department of Justice
Fish and Richardson
Federal Trade Commission
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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