§314.152. Notice of withdrawal of approval of an application or abbreviated application for a new drug.
21 C.F.R. § 314.152
If the Food and Drug Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a notice in the Federal Register announcing the withdrawal of approval. If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section 505(j)(6) of the act and shall satisfy the requirement of § 314.162(b).
Notes, amendments, and revision history
Amendments
[57 FR 17994, Apr. 28, 1992]
Source
Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted. Redesignated at 57 FR 17983, Apr. 28, 1992.
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.
Source
Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.
Amendments
[57 FR 17994, Apr. 28, 1992]