Source: https://casetext.com/regulation/code-of-federal-regulations/title-21-food-and-drugs/chapter-i-food-and-drug-administration-department-of-health-and-human-services-continued/subchapter-d-drugs-for-human-use/part-314-applications-for-fda-approval-to-market-a-new-drug/subpart-d-fda-action-on-applications-and-abbreviated-applications/314127-refusal-to-approve-an-anda?ref=AsVVwS!B1DRcO
Timestamp: 2019-07-16 08:28:00
Document Index: 112585157

Matched Legal Cases: ['§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314']

§ 314.127 Refusal to approve an ANDA, 21 C.F.R. § 314.127 | Casetext
21 C.F.R. § 314.127
§ 314.127 Refusal to approve an ANDA
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§ 314.126 Adequate and well-controlled studies
§ 314.150 Withdrawal of approval of an application or abbreviated application