Issues

Background

FDA’S NEW APPLICATION NUMBERING FORMAT

Effective immediately, the numbering system for all ANDAs has been revised in order to accommodate FDA’s new application numbering format. This change applies to all pending and approved ANDAs. For all future submissions including new applications, amendments, supplements or other correspondence related to an ANDA, the ANDA number should contain the six digit number with no dashes or commas in the number. This format also applies to INDs. This display scheme has been standardized amongst ALL CDER organizational units including the Office of New Drugs and the Office of Generic Drugs will be required to utilize this numbering format. Likewise, industry is requested to follow the newly designated format. Examples of the “old” and “new” format follow:

Example 1:

Old scheme (now incorrect): ANDA 91-555
New scheme (Correct): ANDA 091555 (note the zero in front of the nine)

Example 2:

Incorrect: ANDA 200,555 or 200-555
Correct: ANDA 200555

Please note: Currently, there is no change in numbering for supplements and annual reports. The format will remain as follows: S-xxx.

Example: 020555