Page 5 - Orange Book Cumulative Supplement 10 October 2012

New additions to the Prescription Drug Product List and OTC Drug
Product List are indicated by the symbol >A>. The Patent and Exclusivity
List new additions are indicated by the symbol >A> to the left of Patent
Number or Exclusivity Code. The >A> symbol is then dropped in subsequent
Cumulative Supplements for that item.

New deletions to the Prescription Drug Product List and OTC Drug Product
List are indicated by the symbol >D> (DELETE) to the left of the line.
The information line with the >D> symbol is dropped in subsequent
Cumulative Supplements for that item.

The Patent and Exclusivity List is arranged in alphabetical order by
active ingredient name(s) and trade name. The trade name will follow the
active ingredient name separated by a dash symbol. Also shown is the
application number and product number (FDA's internal file number) for
reference purposes. All patents with their expiration dates are
displayed for each application number. Drug substance and drug product
patents are indicated as such with DS or DP in the Patent codes column.
Use patents are indicated with the symbol "U" followed by a number
representing a specific use. Exclusivity information for a specific drug
is indicated by an abbreviation followed by the date upon which the
exclusivity expires. Refer to the Exclusivity Terms, Section B, in the
Patent and Exclusivity Information Addendum for an explanation of all
codes and abbreviations. Refer to Section 1.3 for internet access to the
most current list of Patent and Exclusivity terms.

1.2 CUMULATIVE SUPPLEMENT CONTENT

Since February 2005, we have been providing daily Electronic Orange Book
(EOB) product information for new generic drug approvals. Daily generic
updates provide the consumer with the current list of approved generic
products which is important for substitution purposes. Previously, a
first-time-generic product approved early in the month would not be
published in the Cumulative Supplement (CS) for several weeks.

The CS monthly update publish goal is by the end of the following month’s
second work week (e.g., November’s supplement will be updated by the end
of the second full work week in December).

Currently, the monthly PDF CS includes:

 Generic product ANDA (Abbreviated New Drug Approval) approvals as of
the date of publication.

 All product changes received and processed as of the date of
publication.
o Refer to CS Section 1.8 Cumulative Supplement Legend for
types of changes
o Discontinued products will be processed as of the date of
publication. There will be circumstances where a product is
discontinued in one month, however, it will be reported in
a different month's CS. For example, the Orange Book Staff
received a letter November 7 that the product has been
discontinued from manufacturing and marketing. The Orange
Book subsequently publishes the October CS on November 14.
The product will show in the October CS that it is
discontinued even though the date of discontinuance is the
day that the Orange Book Staff receives notification (November 7).

 New Drug Application (NDA) approvals (20,000 and 50,000 series)
appear in the CS month they were approved.

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