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Regulations last checked for updates: May 23, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 314
Subpart C - Subpart C—Abbreviated Applications
§ 314.92 - Drug products for which abbreviated applications may be submitted.
§ 314.93 - Petition to request a change from a listed drug.
§ 314.94 - Content and format of an ANDA.
§ 314.95 - Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
§ 314.96 - Amendments to an unapproved ANDA.
§ 314.97 - Supplements and other changes to an approved ANDA.
§ 314.98 - Postmarketing reports.
§ 314.99 - Other responsibilities of an applicant of an ANDA.
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
353
,
355
,
355
a,
355
f,
356
,
356
a,
356
b,
356
c,
356
e,
360cc
,
371
,
374
,
379e
,
379k
source:
50 FR 7493, Feb. 22, 1985, unless otherwise noted.
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