2007P-0076: ANDA Suitability for Promethazine Hydrochloride and Hydrocodone Bitartrate Syrup, 6.25 MG/2.5 MG Per 5 ML and 6.25 MG/1.67 MG Per 5 ML

CP1 Table of Contents

Sovereign Pharmaceuticals, Ltd. Petition Letter (pdf)

Attachments:

A. Labeling for the reference listed drug, Prometh w/Codeine(PromethazineHydrochloride andCodeine Phosphate Syrup, 6.25 mgand 10 mg/5ml). (pdf)

B. Electronic Orange Book listing for Prometh w/Codeine(PromefhazineHydrochloride andCodeine PhosphateSyrup, 6.25 mgand i0mg/5mL). (pdf)

C. Proposed labeling for Promethazine HCIandHydrocodone Bitartrate, 6.25 mg/ 2.5 mgper5mLandfor Promethazine HCI and HydrocodoneBitartrafe Syrup, 6.25 mg/ 1 . 67 mgper5mL. (pdf)

D. Side by Side Comparison of the Package Inserts for the reference listed drug, Prometh w/Codeine (Promethazine Hydrochloride andCodeine PhosphateSyrup, 6.25mgand 10 mg/5 mL)andthe proposed product, Promethazine HCI andHydrocodoneBifartrate, 6.25 mg/2.5 mgper5mL andforPromethazine HCI andHydrocodoneBifartrate Syrup, 6.25mg/1.67mgperSmL. (pdf)

E. Electronic Orange Book listing for Tussionex~ PennkineticC9 (hydrocodone polisterex andchlorpheniramine polistirex) Extended Release Suspension and CodeprexTM Pennkinefic~ (codeine polisterex andchlorpheniramine polistirex)Extended Release Suspension (pdf)

F. Labeling for TussionexC9 PennkineticC9 (hydrocodonepolisterex and chlorpheniramine polistirex) Extended Release Suspension and Codeprexr"' Pennkinetic~ (codeine polisterex andchlorpheniramine polistirex) Extended Release Suspension (pdf)

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