Title 21

PART 314 SUBPART C

Subpart C - Abbreviated Applications Source:57 FR 17983, Apr. 28, 1992, unless otherwise noted.

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.
• Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

21:5.0.1.1.4.3.1.1	SECTION 314.92	314.92 Drug products for which abbreviated applications may be submitted.
21:5.0.1.1.4.3.1.2	SECTION 314.93	314.93 Petition to request a change from a listed drug.
21:5.0.1.1.4.3.1.3	SECTION 314.94	314.94 Content and format of an ANDA.
21:5.0.1.1.4.3.1.4	SECTION 314.95	314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
21:5.0.1.1.4.3.1.5	SECTION 314.96	314.96 Amendments to an unapproved ANDA.
21:5.0.1.1.4.3.1.6	SECTION 314.97	314.97 Supplements and other changes to an approved ANDA.
21:5.0.1.1.4.3.1.7	SECTION 314.98	314.98 Postmarketing reports.
21:5.0.1.1.4.3.1.8	SECTION 314.99	314.99 Other responsibilities of an applicant of an ANDA.

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