Verteporfin Injectable Solution
- Brand(s)
- Visudyne
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Qlt Ophthalmics, Inc. (2010-04-07)
- Oldest Current Product
- 2000-04-12
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\VERTEPORFIN
- FDAOB
- INJECTION\INJECTION\VERTEPORFIN\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\VERTEPORFIN
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\VERTEPORFIN
product(s) by strength(s)
verteporfin 2 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 502360001 | Visudyne | NDA | Qlt Ophthalmics, Inc. | 2000-04-12 | VERTEPORFIN | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA021119 | 31512723-9ff0-4e18-aa3a-55ab833038c6 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA021119 | VISUDYNE | VALEANT PHARMACEUTICALS LUXEMBOURG SARL | 2000-04-12 | p5770619, USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN THE EYE p5756541, USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN THE EYE p5707608 p5798349, USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN THE EYE | NDA021119_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA021119_001 | RX | VERTEPORFIN (15MG/VIAL) | INJECTION | True | 2000-04-12 | VISUDYNE |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5707608 (view patent) | 2015-08-02 | NDA021119 |
| 2 | p5756541 (view patent) | 2016-03-11 | NDA021119 |
| 3 | p5770619 (view patent) | 2015-01-06 | NDA021119 |
| 4 | p5798349 (view patent) | 2015-08-25 | NDA021119 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 31512723-9ff0-4e18-aa3a-55ab833038c6 (view SPL) | VISUDYNE (VERTEPORFIN FOR INJECTION) | prescription | Human Prescription | Qlt Ophthalmics, Inc. | 2010-04-07 | 2 | 502360001 | |
| 2 | 952f4c80-50b1-4308-9ee6-311ffefb13df (view SPL) | VISUDYNE (VERTEPORFIN FOR INJECTION) | prescription | Human Prescription | Valeant Pharmaceuticals North America Llc | MANUFACTURE | 2014-02-27 | 4 | 001875600 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII