"
"
2.1 Key Sections for Using the Drug Product Lists
This publication contains illustrations, along with Drug Product Lists,
indices, and lists of abbreviations and terms which facilitate their use.
Illustrations. The annotated Drug Product Illustration, see Section
2.2, and the Therapeutic Equivalence Evaluations Illustration, see
Section 2.3, are offered to provide further clarification. These depict the
format found in the Prescription Drug Product List (the only list in which
therapeutic equivalence evaluation codes are displayed).
Drug Product Lists. The Prescription and OTC Drug Product Lists,
arranged alphabetically by active ingredient(s), contain product
identification information (active ingredients, dosage forms, routes of
administration, product names, application holders, strengths) for single and
multiple ingredient drug products. Also shown are the application number and
drug product number (FDA internal computer data use only) and approval dates
for those drug products approved on or after January 1, 1982. The application
number preceded by “N” is a New Drug Application (NDA or commonly the
innovator). The application number preceded by an “A” is an Abbreviated New
Drug Application (ANDA or commonly the generic).
The Discontinued Product List, arranged alphabetically by active
ingredient(s), contains product identification information (dosage form,
product name, strength, and application number).
If a prescription drug product is available from more than one source
(multisource), a therapeutic equivalence code will appear in front of the
applicant's name. If a product is therapeutically equivalent to one or more
products or to an appropriate reference, it will be designated with a code
beginning with "A" and the entry will be underlined and printed in bold font
for emphasis.
Active ingredient headings for multiple ingredient (combination) drug
products are arranged alphabetically. For purposes of this publication, this
alphabetical sort takes precedence over United States Pharmacopeia official
monograph order (i.e., Reserpine, Hydralazine Hydrochloride,
Hydrochlorothiazide). For example, product information labeled as Reserpine,
Hydrochlorothiazide and Hydralazine Hydrochloride appears under the active
ingredient heading Hydralazine Hydrochloride; Hydrochlorothiazide; Reserpine.
A cross-reference to the product information (for prescription and OTC
products) appears for each additional active ingredient in the product. For
combination drug products, the ingredient strengths are separated by
semicolons and appear in the same relative sequence as the ingredients in the
heading. Available strengths of the dosage form from an applicant appear on
separate lines.
To use the Drug Product Lists, determine by alphabetical order the
ingredient under which the product information is listed, using the Product
Name Index, if necessary. Then, find the ingredient in the applicable Drug
Product List. Proceed to the dosage form and route of administration and
compare products within that ingredient heading only. Therapeutic equivalence
or inequivalence for prescription products is determined on the basis of the
therapeutic equivalence codes provided within that specific dosage form and
route heading. The OTC Drug Product List, Discontinued Drug Product List, and
Drug Products with Approval under Section 505 of the Act Administered by the
Center for Biologics Evaluation and Research List have their data arranged
similarly.
The Discontinued Drug Product List contains approved products that have
never been marketed, have been discontinued from marketing, are for military
use, or have had their approvals withdrawn for other than safety or efficacy
reasons subsequent to being discontinued from marketing. All products having
st
a "@" in the 12th Cumulative Supplement of the 31
Edition List have been
nd
added to the Discontinued Drug Product List appearing in the 32
Edition. In
addition, approved drug products that are not in the commercial distribution
channel e.g., approved drug products in applications for export only are also
listed in the Discontinued Section of the Orange Book.
Product Name Index (Prescription and OTC Drug Product Lists). This is an
index of drug products by established or trade name. The second term of each
entry indicates the active ingredient name under which product information can
be found in the appropriate Drug Product List. For those drug products with
multiple active ingredients, only the first active ingredient (in alphabetical
order) will appear. OTC products are so designated.
Product Name Index Listed by Applicant (Prescription and OTC Drug
Product Lists). This is an index that cross-references applicants to drug
products. The bolded and underlined entry represents the applicant name
abbreviation used in this publication. Each complete applicant name that is
represented by the abbreviated name is marked with an asterisk (*). Listed
under each complete applicant name is the first alphabetically arranged
ingredient under which product information can be found in the appropriate
Drug Product List. OTC products are so designated. To use the Drug Product
Lists, determine by alphabetical order the ingredient under which the product
information is listed, using the Product Name Index, if appropriate.
Uniform Terms. To improve readability, uniform terms are used to
designate dosage forms, routes of administration, and abbreviations used to
express strengths. These terms are listed in Appendix C. In some cases, the
terms used may differ from those used in product labels and other labeling.
THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY. IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE PRESCRIPTION DRUG PRODUCT LIST.
(OR ANY CONSIDERED
BP NOT
) ARE
"B"
TO THOSE CODED
NOT
AND
A")
CODES REFER TO SECTION 1.7 OF THE
TE
(OR ANY CODE BEGINNING WITH A
BP
(OR ANY CODE BEGINNING WITH AN
) UNDER AN INGREDIENT AND DOSAGE FORM HEADING ARE CONSIDERED
AB
"A"
(OR ANY CODE BEGINNING WITH AN
) AND ANY PRODUCTS NOT LISTED. DRUG PRODUCTS CODED
AB
"B"
THERAPEUTIC EQUIVALENCE EVALUATIONS ILLUSTRATION
2.3
THERAPEUTICALLY EQUIVALENT ONLY TO OTHER PRODUCTS CODED
DRUG PRODUCTS CODED
CODE BEGINNING WITH THERAPEUTICALLY EQUIVALENT TO ANY OTHER PRODUCT. FOR A COMPLETE EXPLANATION OF THE
INTRODUCTION.
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