Type of regulatory submission / activity (e.g. initial, variation, renewal). Regionally defined.
| Term | Code | Agency | Status |
|---|---|---|---|
| ActStatusActive | active | FDA | — |
| New Drug Application (NDA) | us_application_type_1 | FDA | — |
| Premarket Notification 510k (510K) | us_application_type_10 | FDA | — |
| Abbreviated New Drug Application (ANDA) | us_application_type_2 | FDA | — |
| Biologic License Application (BLA) | us_application_type_3 | FDA | — |
| Investigational New Drug (IND) | us_application_type_4 | FDA | — |
| Drug Master File (MF) | us_application_type_5 | FDA | — |
| Emergency Use Authorization (EUA) | us_application_type_6 | FDA | — |
| Investigational Device Exemption (IDE) | us_application_type_7 | FDA | — |
| Premarket Approval Application (PMA) | us_application_type_9 | FDA | — |
| Original Application | us_submission_type_1 | FDA | — |
| Periodic Safety Reports | us_submission_type_10 | FDA | — |
| REMS Supplement | us_submission_type_11 | FDA | — |
| Efficacy Supplement | us_submission_type_2 | FDA | — |
| Chemistry Manufacturing Controls Supplement | us_submission_type_3 | FDA | — |
| Labeling Supplement | us_submission_type_4 | FDA | — |
| Annual Report | us_submission_type_5 | FDA | — |
| Product Correspondence | us_submission_type_6 | FDA | — |
| Postmarketing Requirements or Postmarketing Commitments | us_submission_type_7 | FDA | — |
| Promotional Labeling Advertising | us_submission_type_8 | FDA | — |
| IND Safety Reports | us_submission_type_9 | FDA | — |
| Original | us_submission_unit_type_1 | FDA | — |
| Presubmission | us_submission_unit_type_2 | FDA | — |
| Application | us_submission_unit_type_3 | FDA | — |
| Amendment | us_submission_unit_type_4 | FDA | — |
| Resubmission | us_submission_unit_type_5 | FDA | — |
| Report | us_submission_unit_type_6 | FDA | — |
| Correspondence | us_submission_unit_type_7 | FDA | — |
28 terms shown for FDA. Data sourced from public health authority publications and updated periodically.