eCTD Codes for Application Types
An eCTD code is assigned for each application type.
- Application Type - The related Application Type Name.
- Applicable DTD/Schema - The active DTD or Schema from the Assembly DTD/Schema Types.
- eCTD Code - The eCTD Code for the DTD or Schema.
- Agency Abbreviation - The abbreviation used as an application prefix for cross-application references.
- Limit to Cross Application Only - Determines if the eCTD Code should be used only in the cross-reference-application-number element on the envelope. Only values set to No appear in the Application Type drop-down list on the Envelope.
| Application Type (Display) | Applicable DTD/Schema | eCTD Code | Agency Abbreviation | Limit to Cross Application Only |
|---|---|---|---|---|
| Abbreviated Biologic New Drug Submission | ca-1-0 | ABNDS | No | |
| Abbreviated Biologic New Drug Submission | ca-2-2 | ABNDS | No | |
| Abbreviated New Drug Application | us-3-3 | fdaat2 | anda | No |
| Abbreviated New Drug Application | us-2-01 | anda | No | |
| Abbreviated New Drug Submission | ca-1-0 | ANDS | No | |
| Abbreviated New Drug Submission | ca-2-2 | ANDS | No | |
| Administrative Submission | ca-1-0 | ADMIN | No | |
| Administrative Submission | ca-2-2 | ADMIN | No | |
| Biologic License Application | us-3-3 | fdaat3 | bla | No |
| Biologic License Application | us-2-01 | bla | No | |
| Clinical Trial Application | ca-1-0 | CTA | No | |
| Clinical Trial Application | ca-2-2 | CTA | No | |
| Drug Identification Number Submission - all types | ca-1-0 | DIN | No | |
| Drug Identification Number Submission - all types | ca-2-2 | DIN | No | |
| Drug Master File | us-3-3 | fdaat5 | mf | No |
| Drug Master File | us-2-01 | dmf | No | |
| Drug Master File (master) | us-2-01 | master-file | No | |
| Emergency Use Authorization | us-3-3 | fdaat6 | No | |
| Investigational Device Exemption | us-3-3 | fdaat7 | Yes | |
| Investigational New Drug | us-3-3 | fdaat4 | ind | No |
| Investigational New Drug | us-2-01 | ind | No | |
| New Drug Application | us-3-3 | fdaat1 | nda | No |
| New Drug Application | us-2-01 | nda | No | |
| New Drug Submission | ca-1-0 | NDS | No | |
| New Drug Submission | ca-2-2 | NDS | No | |
| Notifiable Change | ca-1-0 | NC | No | |
| Notifiable Change | ca-2-2 | NC | No | |
| Premarket Approval Application | us-3-3 | fdaat9 | Yes | |
| Premarket Notification 510k | us-3-3 | fdaat10 | Yes | |
| Safety Issue (FDA Use Only) | us-3-3 | fdaat8 | No | |
| Supplemental Abbreviated Biologic New Drug Submission | ca-1-0 | ABSNDS | No | |
| Supplemental Abbreviated Biologic New Drug Submission | ca-2-2 | ABSNDS | No | |
| Supplemental Abbreviated New Drug Submission | ca-1-0 | SANDS | No | |
| Supplemental Abbreviated New Drug Submission | ca-2-2 | SANDS | No | |
| Supplemental New Drug Submission | ca-1-0 | SNDS | No | |
| Supplemental New Drug Submission | ca-2-2 | SNDS | No |