Dihematoporphyrin Ether Injectable Solution
- Brand(s)
- Photofrin
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Pinnacle Biologics, Inc. (2015-03-31)
- Oldest Current Product
- 1995-12-27
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\DIHEMATOPORPHYRIN ETHER
- FDAOB
- INJECTION\INJECTION\PORFIMER SODIUM\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PORFIMER SODIUM
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PORFIMER
product(s) by strength(s)
dihematoporphyrin ether 2.5 mg/ml injectable solution
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 761280155 | Photofrin | NDA | Pinnacle Biologics, Inc. | 1995-12-27 | PORFIMER SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | NDA020451 | 5c4841b4-fbc0-4163-8ee1-cb28629cbfbf |
| # | id | title | applicant | approved | approved drug |
|---|
| 1 | NDA020451 | PHOTOFRIN | CONCORDIA LABORATORIES INC | 1995-12-27 | NDA020451_001 |
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|
| 1 | NDA020451_001 | RX | PORFIMER SODIUM (75MG/VIAL) | INJECTION | False | 1995-12-27 | PHOTOFRIN |
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|
| 1 | 5c4841b4-fbc0-4163-8ee1-cb28629cbfbf (view SPL) | These highlights do not include all the information needed to use PHOTOFRIN safely and effectively. See full prescribing information for PHOTOFRIN. PHOTOFRIN (porfimer sodium) INJECTIONInitial U.S. Approval: 1995 | prescription | Human Prescription | Pinnacle Biologics, Inc. | 2015-03-31 | 4 | 761280155 |