Explanation of "generic" tags:
As a new feature in the Orange Book
Companion line of products and services, we are attempting to identify
branded drug products for which there is an approved generic equivalent.
In this way our customers will be signaled that, despite the branded product
having patents or exclusivities listed in the FDA Orange Book, it is subject
to generic competition.
Prescription products for which we have identified a rated generic are
tagged with their Therapeutic Equivalence (TE) Code, as follows: [GENERIC XX] where XX is the TE Code. For an description
of TE Codes, see
the FDA's web site.
Prescription products
for which a similar generic drug has been approved (based upon their having
the same active ingredient, dosage form & route of administration,
and strength), but which do not have identical TE Codes are tagged as
follows: [Has competitive generic]
OTC products that we believe are the subject of an approved generic (based upon the generic also being OTC and having
the same active ingredient, dosage form & route of administration,
and strength) are tagged as follows:
[GENERIC OTC]
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