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2006P-0397
CP 1
Volume 1

Citizen Petition

Enclosure 1 - Labeling of the Proposed Product - Fexofenadine Hydrochloride for Oral Suspension 30 mg/5 mL and 60 mg/5 mL

Enclosure 2 - Labeling of the Reference Listed Drug Product - Allegra (fexfenadine hydrochloride) Tablets, 30 mg, 60 mg, & 180 mg [NDA #20-872, Holder - Sanofi Aventis] Published Material

Enclosure 3 - Summary of the Well Controlled Studies in Pediatric Patients using Allegra

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Page last updated October 18, 2006 RSChorizonal rule
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