Regulations.gov document

Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry

Other · FDA-2017-D-5974 · posted Oct 13, 2017

Key facts

Document ID FDA-2017-D-5974-0002
Title Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry
Document type Other
Subtype Guidance
Agency FDA
Docket FDA-2017-D-5974
Posted Oct 13, 2017
Comment period opens Oct 13, 2017
Comments due Dec 13, 2017

At a glance

  • No Open for comment
  • 1–9 Public comments on this docket

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Regulations.gov documents

Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.

Source: Regulations.gov (U.S. General Services Administration eRulemaking Program) · Source date:

Browse all Regulations.gov documents