See 21 C.F.R. 314.50 Content and format of an NDA
See 21 C.F.R. 314.52 Notice of certification of invalidity, unenforceability, or non infringement of a patent
See 21 C.F.R. 314.53 Submission of patent information
See 21 C.F.R. 314.54 Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
See 21 C.F.R. 314.60 Amendments to an unapproved NDA, supplement, or resubmission
See 21 C.F.R. 314.70 Supplements and other changes to an approved NDA
See 21 C.F.R. 314.94 Content and format of an ANDA
See 21 C.F.R. 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent
See 21 C.F.R. 314.96 Amendments to an unapproved ANDA
See 21 C.F.R. 314.97 Supplements and other changes to an ANDA
See 21 C.F.R. 314.101 Filing an NDA and receiving an ANDA
See 21 C.F.R. 314.107 Date of approval of a 505(b)(2) application or ANDA
See 21 C.F.R. 314.108 New drug product exclusivity
See 21 C.F.R. 316.31 Scope of orphan-drug exclusive approval
See 21 C.F.R. 316.34 FDA recognition of exclusive approval
