Abbreviated New Drug Applications and 505(b)(2) Applications

OMB 0910-0786

Latest Forms, Documents, and Supporting Material

Document Name
Form Form FDA 3542 Abbreviated New Drug Applications and 505(b)(2) Applications Form and Instruction
0786 FRIA 6 OCT 2016 FR.pdf Supplementary Document
0786 SS for FR Oct 2016.pdf Supporting Statement A
Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(i) of the Act
Supplements and other changes to an approved abbreviated application
Supplements and other changes to an approved abbreviated application
Amendments to an unapproved abbreviated application
Amendments to an unapproved abbreviated application
Notice of certification of invalidity or noninfringement of a patent
Content and format of an abbreviated application
Supplements and other changes to an approved application
Amendments to an unapproved application, supplement, or resubmission
Submission of patent information
Notice of certification of invalidity or infringement of a patent
Notice of certification of invalidity or infringement of a patent
Content and format of an application
Abbreviated New Drug Applications and 505(b)(2) Applications Form and Instruction