Application 214907
- Type
- NDA
- Sponsor
- ON TARGET LABROTORIES, INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CYTALUX | PAFOLACIANINE | INJECTABLE;INJECTION | 3.2MG/1.6ML (2MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 81052-138 | Cytalux | Pafolacianine injection | On Target Laboratories, Inc. | NDA | Current |
| 81052-138 | Cytalux | Pafolacianine injection | On Target Laboratories, Inc. | NDA | Current |
| 81052-138 | Cytalux | Pafolacianine injection | On Target Laboratories, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72927 | SUPPL | 2022-12-20 |
| 72926 | SUPPL | 2022-12-19 |
| 69746 | ORIG | 2021-12-22 |
| 69426 | ORIG | 2021-11-30 |
| 69422 | ORIG | 2021-11-30 |