FDA Action on Applications and Abbreviated Applications | Midpage

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Code of Federal Regulations

Subpart D

FDA Action on Applications and Abbreviated Applications

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of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.314.161Determination of reasons for voluntary withdrawal of a listed drug.314.162Removal of a drug product from the list.314.170Adulteration and misbranding of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