Page 4 - Orange Book Cumulative Supplement 10 October 2012

APPROVED DRUG PRODUCTS
with
THERAPEUTIC EQUIVALENCE EVALUATIONS

32nd EDITION

CUMULATIVE SUPPLEMENT 10
October 2012

1.0 INTRODUCTION

1.1 HOW TO USE THE CUMULATIVE SUPPLEMENT

This Cumulative Supplement is one of a series of monthly updates to the
Approved Drug Products with Therapeutic Equivalence Evaluations, 30th
Edition (the List). The List is composed of four parts: approved
prescription drug products with therapeutic equivalence evaluations;
over-the-counter (OTC) drug products that require approved applications
as a condition of marketing; drug products with approval under Section
505 of the Act administered by the Center for Biologics Evaluation and
Research; and products that have never been marketed, are for
exportation, are for military use, have been discontinued from marketing
or that have had their approvals withdrawn for other than safety or
efficacy reasons.

The Cumulative Supplement provides, among other things, information on
newly approved drugs and, if necessary, revised therapeutic equivalence
evaluations and updated patent and exclusivity data. The Addendum
contains appropriate drug patent and exclusivity information required of
the Agency by the "Drug Price Competition and Patent Term Restoration Act
of 1984" for the Prescription, OTC, and Drug Products with Approval under
Section 505 of the Act Administered by the Center for Biologics
Evaluation and Research Lists.

Because all parts of the publication are subject to changes, additions,
or deletions, the List must be used in conjunction with the most current
Cumulative Supplement. Users may wish to mark to the left of the
ingredient(s) in the List to indicate that changes to that entry appear
in the Cumulative Supplement. Drug product information is provided in
each Cumulative Supplement for completeness to assist in locating the
proper place in the List for the revision.
The presence of any therapeutic equivalence code indicates that the drug
product is multisource; the deletion of a therapeutic equivalence code
indicates that the drug product has become single source. (An infrequent
exception exists when a therapeutic equivalence code is revised. In that
case, the deletion of the therapeutic equivalence code is followed
immediately by the addition of the revised one.)

Products that have never been marketed, are for exportation, are for
military use, or have been discontinued from marketing or that have had
their approvals withdrawn for other than safety or efficacy reasons, will
be flagged in this Cumulative Supplement with the "@" symbol to designate
their non-marketed status. All products having a "@" symbol in the 12th
Cumulative Supplement of the 32nd Edition List will then be added to the
"Discontinued Drug Product List" appearing in the 33rd Edition. The
current Edition Section 2., How To Use The Drug Product Lists, describes
the layout and usage of the List.

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