2007P-0194:ANDA Suitability for Acetaminophen, Butalbital, Caffeine and Hydrocodone Bitartrate Capsules, 650 mg / 50 mg /40 mg / 5 mg

CP1 Table of Contents

CP Letter

Attachments:

• Approved Drug Products with Therapeutic Equivalence Evaluations, Electronic Orange Book listing, accessed 4/24/2007
• Approval Letter for Citizen Petition 99P-1657, dated April 14, 2000
• Approval Letter for Citizen Petition 99P-2150, dated April 14, 2000
• Approval Letter for Citizen Petition 93P-0346, dated November 15, 1994
• Approved labeling for reference-listed drug, Fioricet wtih Codeine Capsultes
• Draft insert labeling for proposed product