ioxilan Injectable Solution
- Brand(s)
- Oxilan
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Guerbet Llc (2015-09-14)
- Oldest Current Product
- 2002-03-18
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\IOXILAN
- FDAOB
- INJECTION\INJECTION\IOXILAN\rdfq
- SPL Active
- INTRAVASCULAR\INJECTION, SOLUTION\IOXILAN
- SPL Moiety
- INTRAVASCULAR\INJECTION, SOLUTION\IOXILAN
product(s) by strength(s)
ioxilan 623 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 676841000 | Oxilan | NDA | Guerbet Llc | 2002-03-18 | 2016-04-30 | IOXILAN | INTRAVASCULAR | INJECTION, SOLUTION | NDA020316 | ae692163-dfbf-4271-87ad-4ed888caa513 |
ioxilan 727 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 676841001 | Oxilan | NDA | Guerbet Llc | 2002-03-18 | 2016-04-30 | IOXILAN | INTRAVASCULAR | INJECTION, SOLUTION | NDA020316 | ae692163-dfbf-4271-87ad-4ed888caa513 |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | NDA020316 | OXILAN-300 | GUERBET LLC | 1995-12-21 | NDA020316_001, NDA020316_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA020316_001 | RX | IOXILAN (62%) | INJECTION | False | 1995-12-21 | OXILAN-300 |
| 2 | NDA020316_002 | RX | IOXILAN (73%) | INJECTION | False | 1995-12-21 | OXILAN-300 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ae692163-dfbf-4271-87ad-4ed888caa513 (view SPL) | OXILAN (Ioxilan Injection) 300 mgI/mLOXILAN (Ioxilan Injection) 350 mgI/mLOXILAN (Ioxilan Injection) 300 mgI/mL Pharmacy Bulk Package Nonionic Contrast Agents | prescription | Human Prescription | Guerbet Llc | analysis, api manufacture, manufacture, pack | 2015-09-14 | 10 | 676841000, 676841001 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII