eCTD Filing Types for US
Calyx RIM provides the following filing types for all application types associated with the United States (US). This table lists the eCTD code and the applicable DTD or Schema for each Filing Type.
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Types |
|---|---|---|---|
| Amendment Filing | us-2-01 | amendment | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Annual Report Filing | us-2-01 | annual-report | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| CMC Supplement | us-2-01 | chemistry-manufacturing-controls-supplement | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Efficacy Supplement | us-2-01 | efficacy-supplement | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Labeling Supplement | us-2-01 | labeling-supplement | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Original Filing | us-2-01 | original-application | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Other Filing | us-2-01 | other | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Presubmission Filing | us-2-01 | presubmission | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Re-submission Filing | us-2-01 | resubmission | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Supplement Filing | us-2-01 | establishment-description-supplement | ANADA, ANDA, BLA, CNADA, DAPM, DMF, MASTER, EUA, IDE, INAD, IND, NADA, NDA, PMA |
| Annual Report Filing | us-3-3 | fdast5 | NDA, ANDA, BLA, IND, DMF |
| CMC Supplement | us-3-3 | fdast3 | NDA, ANDA, BLA |
| Efficacy Supplement | us-3-3 | fdast2 | NDA, BLA |
| IND Safety Reports | us-3-3 | fdast9 | IND |
| Labeling Supplement | us-3-3 | fdast4 | NDA, ANDA, BLA |
| Original Filing | us-3-3 | fdast1 | IND, NDA, ANDA, BLA, DMF, EUA |
| Periodic Safety Update Report | us-3-3 | fdast10 | NDA, ANDA, BLA |
| Postmarketing Requirements or Postmarketing Commitments | us-3-3 | fdast7 | NDA, BLA |
| Product Correspondence | us-3-3 | fdast6 | NDA, ANDA, BLA, IND, DMF |
| Promotional Labeling Advertising | us-3-3 | fdast8 | NDA, ANDA, BLA |
| REMS Supplement | us-3-3 | fdast11 | ANDA, BLA, NDA |