Floxuridine Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- App Pharmaceuticals, Llc (2012-08-17)
- Oldest Current Product
- 2001-03-15
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\FLOXURIDINE
- FDAOB
- INJECTION\INJECTION\FLOXURIDINE\rdfq
- SPL Active
- INTRA-ARTERIAL\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\FLOXURIDINE
- SPL Moiety
- INTRA-ARTERIAL\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\FLOXURIDINE
product(s) by strength(s)
floxuridine 100 mg/ml injectable solution
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 633230145 | ANDA | App Pharmaceuticals, Llc | 2001-03-15 | FLOXURIDINE | INTRA-ARTERIAL | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA075837 | c8edabc1-67cd-421b-a147-7c1f19f05b8e |
| # | id | title | deprecated | applicant | approved | approved drug |
|---|
| 1 | ANDA075387 | FLOXURIDINE | | EUROHEALTH INTERNATIONAL SARL | 2000-04-16 | ANDA075387_001 |
| 2 | ANDA075837 | FLOXURIDINE | | FRESENIUS KABI USA LLC | 2001-02-22 | ANDA075837_001 |
| 3 | NDA016929 | FUDR | True | HOSPIRA INC | | NDA016929_001 |
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|
| 1 | ANDA075387_001 | RX | FLOXURIDINE (500MG/VIAL) | INJECTION | True | AP | 2000-04-16 | FLOXURIDINE |
| 2 | ANDA075837_001 | RX | FLOXURIDINE (500MG/VIAL) | INJECTION | False | AP | 2001-02-22 | FLOXURIDINE |
| 3 | NDA016929_001 | discontinued | FLOXURIDINE (500MG/VIAL) | INJECTION | False | | | FUDR |
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|
| 1 | c8edabc1-67cd-421b-a147-7c1f19f05b8e (view SPL) | Floxuridine for Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2012-08-17 | 1 | 633230145 |