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Application 020451
- Type
- NDA
- Sponsor
- PINNACLE BIOLGS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PHOTOFRIN | PORFIMER SODIUM | INJECTABLE;INJECTION | 75MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 76128-155 | Photofrin | Porfimer Sodium | Pinnacle Biologics, Inc. | NDA | Current |
| 76128-155 | Photofrin | Porfimer Sodium | Pinnacle Biologics, Inc. | NDA | Current |
| 76128-155 | Photofrin | Porfimer Sodium | Pinnacle Biologics, Inc. | NDA | Current |
| 76128-155 | Photofrin | Porfimer Sodium | Pinnacle Biologics, Inc. | NDA | Current |
| 76128-155 | Photofrin | Porfimer Sodium | Pinnacle Biologics, Inc. | NDA | Current |
| 76128-155 | Photofrin | Porfimer Sodium | Pinnacle Biologics, Inc. | NDA | Current |
| 76128-155 | Photofrin | Porfimer Sodium | Pinnacle Biologics, Inc. | NDA | Current |
| 76128-155 | Photofrin | Porfimer Sodium | Pinnacle Biologics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61516 | SUPPL | 2020-01-06 |
| 61491 | SUPPL | 2020-01-02 |
| 57647 | ORIG | 2019-02-15 |
| 24992 | SUPPL | 2011-07-05 |
| 34675 | SUPPL | 2011-06-28 |
| 2561 | SUPPL | 2011-04-06 |
| 12603 | SUPPL | 2011-04-04 |
| 34674 | SUPPL | 2008-09-09 |
| 2560 | SUPPL | 2008-09-09 |
| 41377 | SUPPL | 2006-07-25 |
| 2559 | SUPPL | 2005-10-20 |
| 24991 | SUPPL | 2003-08-15 |
| 12602 | SUPPL | 2003-08-14 |
| 2558 | SUPPL | 1998-12-22 |
| 2557 | SUPPL | 1998-01-09 |