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... Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg, respectively, to be bioequivalent
and, therefore, therapeutically equivalent to the listed drug (Fioricet ...

UNITED STATES OF AMERICA. + + + + +. DEPARTMENT OF HEALTH AND HUMAN SERVICES. + + + + +.
FOOD AND DRUG ADMINISTRATION. CENTER FOR DRUG EVALUATION AND RESEARCH. ...

Page 1. JUNE 2006 - APPROVED DRUG PRODUCTS LIST APPENDIX A - PRODUCT NAME INDEX
A - 1 ** 8 ** 8-MOP, METHOXSALEN ** A ** A/T/S, ERYTHROMYCIN ...

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Fioricet - Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets, USP) is supplied in tablet form for oral administration.

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ATTACHMENT 4
... t, NOVARTIS T2002-70 89017701 Fioricet@ with Codeine 6 ... Fioricet@ consists of a fixed
combination of butalbital 50 mg, acetaminophen 325 mg and caffeine 40 mg. ...
www.fda.gov/ohrms/dockets/dailys/03/Aug03/082903/03p-0398-cp00001-05-att-4-vol1.pdf - 09-10-2003 - Text Version

[PDF] PaJez!$
... under an ANDA. Fioricet@ wl Codeine (codeine phosphate 30 mg, butalbital 50 mg,
caffeine 40 mg, and ... 325 mg acetaminophen, USP) Fioricet@ with Codeine Comnanv ...
www.fda.gov/ohrms/dockets/dailys/03/Aug03/082903/03p-0398-cp00001-01-vol1.pdf - 09-10-2003 - Text Version
[ More results from www.fda.gov/ohrms/dockets/dailys ]

[PDF] &x3yP-6 560
... The reference-listed drug product upon which this petition is based is Fioricet@
with Codeine (Acetaminophen, Butalbital, Caffeine, and Codeine Phosphate ...
www.fda.gov/ohrms/dockets/dockets/04p0560/04p-0560-cp00001-02-vol1.pdf - 01-11-2005 - Text Version

[PDF] LAcHMANCONSULTANTSERVICES,lNC.
... AWD CAFFBmE 2% AXIOM PHARM 325393;50116;4O?sB -- ESGIC-PLUS e + MIKART
5ooMG;5os;4os -- FIORICET AB + WATSON PHARMS - 32uIG;5Ol1EZ;401E -- ...
www.fda.gov/ohrms/dockets/dockets/04p0561/04p-0561-cp00001-02-vol1.pdf - 01-11-2005 - Text Version
[ More results from www.fda.gov/ohrms/dockets/dockets ]

May 1998 Drug Labeling Changes
... Return to Quick Reference. FIORICET WITH CODEINE (acetaminophen/butalbital/
caffeine/codeine phosphate) Capsules [May 20, 1998: Sandoz]. ...
www.fda.gov/medwatch/safety/1998/may98.htm - 06-27-2006 - Cached

1998 Index - Drug Labeling Changes - MedWatch
Drug Labeling Changes - 1998
www.fda.gov/medwatch/safety/1998/index98.htm - 06-27-2006 - Cached
[ More results from www.fda.gov/medwatch/safety/1998 ]

FDA Enforcement Report
... REASON Product does not meet dissolution specifications. -2- RECALLS AND FIELD
CORRECTIONS: DRUGS -- CLASS III PRODUCT Fioricet, an oral tablet containing ...
www.fda.gov/bbs/topics/ENFORCE/ENF00165.html - 02-18-1998 - Cached

Prescription and Over-the-Counter Drug Product List: 3/2003
detailed description
www.fda.gov/cder/rxotcdpl/pdpl_200303.htm - 01-19-2006 - Cached

Prescription and Over-the-Counter Drug Product List: 4/2003
detailed description
www.fda.gov/cder/rxotcdpl/pdpl_200304.htm - 01-19-2006 - Cached
[ More results from www.fda.gov/cder/rxotcdpl ]

First-Time Generics - January 2003
First-Time Generics -December 2002
www.fda.gov/cder/ogd/approvals/1stgen0103.htm - 04-25-2006 - Cached