[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.117]
[Page 217]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20 PUBLIC INFORMATION--Table of Contents
Subpart F Availability of Specific Categories of Records
Sec. 20.117 New drug information.
(a) The following computer printouts are available for public
inspection in the Food and Drug Administration's Freedom of Information
Public Room:
(1) A numerical listing of all new drug applications and abbreviated
new drug applications approved since 1938, showing the NDA number, the
trade name, the applicant, the approval date, and, where applicable, the
date the approval was withdrawn and the date the Food and Drug
Administration was notified that marketing of the product was
discontinued.
(2) A numerical listing of all new drug applications and abbreviated
new drug applications approved since 1938 which are still approved,
showing the same information as is specified in paragraph (a)(1) of this
section except that it does not show a withdrawal date.
(3) A listing of new drug applications, abbreviated new drug
applications, which were approved since 1938 and which are still
approved, covering marketed prescription drug products except
prescription drug products covered by applications deemed approved under
the Drug Amendments of 1962 and not yet determined to be effective in
the Drug Efficacy Study Implementation program. The listing includes the
name of the active ingredient, the type of dosage form, the route of
administration, the trade name of the product, the name of the
application holder, and the strength or potency of the product. The
listing also includes, for each active ingredient in a particular dosage
form for which there is more than one approved application, an
evaluation of the therapeutic equivalence of the drug products covered
by such applications.
(b) Other computer printouts containing IND and NDA information are
available to the extent that they do not reveal data or information
prohibited from disclosure under Sec. Sec. 20.61, 312.130, and 314.430
of this chapter.
[42 FR 15616, Mar. 22, 1977, as amended at 45 FR 72608, Oct. 31, 1980;
46 FR 8457, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989; 64 FR 399, Jan. 5,
1999]
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