04P-0140

CP 1

Volume 1

 

Petition

Tab 1 - 01P-0117 PAV 1

Tab 2 - 01P-0481 PAV 1

Tab 3 - Letter, MEDWATCH to Elan Pharmaceuticals, Inc.

Tab 4 - Letter, CDER to Elan Pharmaceuticals, Inc.

Tab 5 - Letter, CDER to King Pharmaceuticals, Inc.

Tab 6 - Letter, CDER to King Pharmaceuticals, Inc.

Tab 7 - Declaration of Michael E. Elia

part 2 - CV

Tab 8 - Guidance: Food-Effect Bioavailability and Fed Bioequivalence Studies

Tab 9 - Guidance: In Vivo Drug Metabolism/Drug Interaction Studies

Tab 10 - Declaration of Leslie Z. Benet, PhD

part 2 - CV

Tab 11 - 03P-0027 CP 1