Application 214793
- Type
- NDA
- Sponsor
- PROGENICS PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PYLARIFY | PIFLUFOLASTAT F 18 | INJECTABLE;INJECTION | 2960MBQ/ML(1MCI/ML,80MCI/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71258-022 | PYLARIFY | PIFLUFOLASTAT F-18 | Progenics Pharmaceuticals, Inc. | NDA | Current |
| 71258-022 | PYLARIFY | PIFLUFOLASTAT F-18 | Progenics Pharmaceuticals, Inc. | NDA | Current |
| 71258-022 | PYLARIFY | PIFLUFOLASTAT F-18 | Progenics Pharmaceuticals, Inc. | NDA | Current |
| 71258-022 | PYLARIFY | PIFLUFOLASTAT F-18 | Progenics Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67750 | ORIG | 2021-06-09 |
| 67610 | ORIG | 2021-05-27 |
| 67608 | ORIG | 2021-05-27 |