Page 3 - Orange Book Cumulative Supplement 10 October 2012

APPROVED DRUG PRODUCTS
with
THERAPEUTIC EQUIVALENCE EVALUATIONS

nd
32 EDITION

Cumulative Supplement 10

October 2012

CONTENTS

PAGE

1.0 INTRODUCTION ........................................................................................................................................ iii

1.1 How to use the Cumulative Supplement ........................................................................................... iii

1.2 Cumulative Supplement Content....................................................................................................... iv
1.3 Applicant Name Changes................................................................................................................... v

1.4 Levothyroxine Sodium...................................................................................................................... .vi

1.5 Availability of the Edition .................................................................................................................. vii

1.6 Report of Counts for the Prescription Drug Product List ..................................................................viii

1.7 Cumulative Supplement Legend ....................................................................................................... ix

DRUG PRODUCT LISTS
Prescription Drug Product List ....................................................................................................... 1-1
OTC Drug Product List .................................................................................................................. 2-1
Drug Products with Approval under Section 505 of the Act
Administered by the Center for Biologics Evaluation and Research List................................... 3-1
Orphan Product Designations and Approvals List ......................................................................... 4-1
Drug Products Which Must Demonstrate in vivo Bioavailability
Only if Product Fails to Achieve Adequate Dissolution ............................................................. 5-1

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM
A. Patent and Exclusivity Lists ................................................................................................... A-1
B. Patent and Exclusivity Terms ................................................................................................ B-1