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Details for New Drug Application (NDA): 088616

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NDA 088616 describes FIORICET, which is a drug marketed by Actavis Labs Ut Inc and is included in two NDAs. It is available from four suppliers. Additional details are available on the FIORICET profile page.

The generic ingredient in FIORICET is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.

Summary for NDA: 088616

Actavis Labs Ut Inc
acetaminophen; butalbital; caffeine

Pharmacology for NDA: 088616

Suppliers and Packaging for NDA: 088616

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; butalbital; caffeine
TABLET;ORAL 088616 ANDA Actavis Pharma, Inc. 0591-3369 0591-3369-01 100 TABLET in 1 BOTTLE (0591-3369-01)
acetaminophen; butalbital; caffeine
TABLET;ORAL 088616 ANDA Actavis Pharma, Inc. 0591-3369 0591-3369-05 500 TABLET in 1 BOTTLE (0591-3369-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Nov 9, 1984TE:AARLD:No

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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.