eCTD Sub-Filing Types for US
Calyx RIM provides the following sub-filing types for all application types associated with the United States (US).
This table lists the eCTD code and the applicable Sub-Filing Type for each Filing Type.
| Country | Specification | Filing Type | Sub-Filing Type | eCTD Code |
|---|---|---|---|---|
| United States | us-3-3 | Annual Report Filing | Amendment | fdasst4 |
| United States | us-3-3 | Annual Report Filing | Report | fdasst6 |
| United States | us-3-3 | CMC Supplement | Amendment | fdasst4 |
| United States | us-3-3 | CMC Supplement | Application | fdasst3 |
| United States | us-3-3 | CMC Supplement | Presubmission | fdasst2 |
| United States | us-3-3 | CMC Supplement | Resubmission | fdasst5 |
| United States | us-3-3 | Efficacy Supplement | Amendment | fdasst4 |
| United States | us-3-3 | Efficacy Supplement | Application | fdasst3 |
| United States | us-3-3 | Efficacy Supplement | Presubmission | fdasst2 |
| United States | us-3-3 | Efficacy Supplement | Resubmission | fdasst5 |
| United States | us-3-3 | IND Safety Reports | Amendment | fdasst4 |
| United States | us-3-3 | IND Safety Reports | Report | fdasst6 |
| United States | us-3-3 | Labeling Supplement | Application | fdasst3 |
| United States | us-3-3 | Labeling Supplement | Presubmission | fdasst2 |
| United States | us-3-3 | Labeling Supplement | Resubmission | fdasst5 |
| United States | us-3-3 | Original Filing | Amendment | fdasst4 |
| United States | us-3-3 | Original Filing | Application | fdasst3 |
| United States | us-3-3 | Original Filing | Presubmission | fdasst2 |
| United States | us-3-3 | Original Filing | Resubmission | fdasst5 |
| United States | us-3-3 | Periodic Safety Update Report | Amendment | fdasst4 |
| United States | us-3-3 | Periodic Safety Update Report | Report | fdasst6 |
| United States | us-3-3 | Postmarketing Requirements or Postmarketing Commitments | Amendment | fdasst4 |
| United States | us-3-3 | Postmarketing Requirements or Postmarketing Commitments | Original | fdasst1 |
| United States | us-3-3 | Product Correspondence | Amendment | fdasst4 |
| United States | us-3-3 | Product Correspondence | Correspondence | fdasst7 |
| United States | us-3-3 | Promotional Labeling Advertising | Amendment | fdasst4 |
| United States | us-3-3 | Promotional Labeling Advertising | Original | fdasst1 |
| United States | us-3-3 | Promotional Labeling Advertising | Resubmission | fdasst5 |