Title 21

PART 314 SUBPART D

Subpart D - FDA Action on Applications and Abbreviated Applications Source:50 FR 7493, Feb. 22, 1985, unless otherwise noted. Redesignated at 57 FR 17983, Apr. 28, 1992.

• 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.

21:5.0.1.1.4.4.1.1	SECTION 314.100	314.100 Timeframes for reviewing applications and abbreviated applications.
21:5.0.1.1.4.4.1.2	SECTION 314.101	314.101 Filing an NDA and receiving an ANDA.
21:5.0.1.1.4.4.1.3	SECTION 314.102	314.102 Communications between FDA and applicants.
21:5.0.1.1.4.4.1.4	SECTION 314.103	314.103 Dispute resolution.
21:5.0.1.1.4.4.1.5	SECTION 314.104	314.104 Drugs with potential for abuse.
21:5.0.1.1.4.4.1.6	SECTION 314.105	314.105 Approval of an NDA and an ANDA.
21:5.0.1.1.4.4.1.7	SECTION 314.106	314.106 Foreign data.
21:5.0.1.1.4.4.1.8	SECTION 314.107	314.107 Date of approval of a 505(b)(2) application or ANDA.
21:5.0.1.1.4.4.1.9	SECTION 314.108	314.108 New drug product exclusivity.
21:5.0.1.1.4.4.1.10	SECTION 314.110	314.110 Complete response letter to the applicant.
21:5.0.1.1.4.4.1.11	SECTION 314.120	314.120 [Reserved]
21:5.0.1.1.4.4.1.12	SECTION 314.122	314.122 Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
21:5.0.1.1.4.4.1.13	SECTION 314.125	314.125 Refusal to approve an NDA.
21:5.0.1.1.4.4.1.14	SECTION 314.126	314.126 Adequate and well-controlled studies.
21:5.0.1.1.4.4.1.15	SECTION 314.127	314.127 Refusal to approve an ANDA.
21:5.0.1.1.4.4.1.16	SECTION 314.150	314.150 Withdrawal of approval of an application or abbreviated application.
21:5.0.1.1.4.4.1.17	SECTION 314.151	314.151 Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
21:5.0.1.1.4.4.1.18	SECTION 314.152	314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.
21:5.0.1.1.4.4.1.19	SECTION 314.153	314.153 Suspension of approval of an abbreviated new drug application.
21:5.0.1.1.4.4.1.20	SECTION 314.160	314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
21:5.0.1.1.4.4.1.21	SECTION 314.161	314.161 Determination of reasons for voluntary withdrawal of a listed drug.
21:5.0.1.1.4.4.1.22	SECTION 314.162	314.162 Removal of a drug product from the list.
21:5.0.1.1.4.4.1.23	SECTION 314.170	314.170 Adulteration and misbranding of an approved drug.

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