Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Federal Trade Commission
Harvard Business School

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017534

« Back to Dashboard

NDA 017534 describes FIORINAL, which is a drug marketed by Allergan Sales Llc and is included in two NDAs. It is available from three 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 017534
Applicant:Allergan Sales Llc
Ingredient:aspirin; butalbital; caffeine
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017534
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIORINAL aspirin; butalbital; caffeine CAPSULE;ORAL 017534 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-3219 N 0591-3219-01
FIORINAL aspirin; butalbital; caffeine CAPSULE;ORAL 017534 NDA AUTHORIZED GENERIC Aidarex Pharmaceuticals LLC 33261-922 N 33261-922-30

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile for product number 005

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Chinese Patent Office

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.