Page 10 - Orange Book Cumulative Supplement 10 October 2012

1.7 CUMULATIVE SUPPLEMENT LEGEND

The List is sorted by Ingredient(s) and, within each grouping, by the
Dosage Form; Route and then by trade name.

The individual product record contains the Therapeutic Equivalence Code,
Reference Listed Drug symbol, applicant holder, strength(s), New Drug
Application number, product number, and approval date. The application
number preceded by “N” is a New Drug Application (NDA or innovator). The
application number preceded by an “A” is an Abbreviated New Drug
Application (ANDA or generic). The last two columns describe the action.
The Action Month is the CS month the action occurred. The OB Action is
the type of change that has occurred.

New ingredient(s), new dosage form; route(s), new trade names, and new
product additions are preceded by >A> during the action month. The change
month is the current CS month; the change code for new approvals is NEWA.
Following months will display the same information without the >A>.

Changes to currently listed products will list two records. The deleted
product record will be proceeded by >D>. The product record change
addition being made will be preceded by >A>. Following months will
display only the >A> record without the >A>. All changes that occur to
the product through the Annual year will be listed. The change month and
change code will document the change.

The change code and description:

NEWA New drug product approval usually in the supplement
month.
CAHN Applicant holder firm name has changed.
CAIN Change. There has been a change in the Ingredient(s) name.
All products will be deleted under the old name and all
products will be added under the changed ingredient(s) name.
CDFR Change. Dosage Form; Route of Administration.
CFTG Change. A first time generic for the innovator product. A
TE Code is added.
CMFD Change. The product is moved from the Discontinued Section
due to a change in marketing status.
CMS1 Change. Miscellaneous addition to list.
CMS2 Change. Miscellaneous deletion from list.
CPOT Change. Potency amount/unit.
CRLD Change. Reference Listed Drug.
CTEC Change. Therapeutic Equivalence Code.
CTNA Change. Trade Name.
DISC Discontinued. The Rx or OTC listed product is not
being marketed and will be moved to the discontinued
section in the next edition.

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