Levofloxacin Ophthalmic Solution
- Brand(s)
- Iquix, Quixin
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Pack Pharmaceuticals Llc (2011-05-04)
- Oldest Current Product
- 2000-10-01
- License(s)
- NDA, ANDA
- RxNORM
- OPHTHALMIC SOLUTION\LEVOFLOXACIN
- FDAOB
- OPHTHALMIC\SOLUTION_DROPS\LEVOFLOXACIN
- SPL Active
- OPHTHALMIC\SOLUTION/DROPS\LEVOFLOXACIN
OPHTHALMIC\SOLUTION\LEVOFLOXACIN
TOPICAL\SOLUTION/DROPS\LEVOFLOXACIN - SPL Moiety
- OPHTHALMIC\SOLUTION/DROPS\LEVOFLOXACIN ANHYDROUS
OPHTHALMIC\SOLUTION\LEVOFLOXACIN
TOPICAL\SOLUTION/DROPS\LEVOFLOXACIN
product(s) by strength(s)
invalid application product(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 686690145 | Iquix | NDA | Vistakon Pharmaceuticals Llc | 2004-06-01 | LEVOFLOXACIN | OPHTHALMIC | SOLUTION | NDA021571 | 067ea8ec-99a3-4a0b-9116-4ffd6160b24b |
levofloxacin 5 mg/ml ophthalmic solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 165710150 | ANDA | Pack Pharmaceuticals Llc | 2010-12-20 | LEVOFLOXACIN | TOPICAL | SOLUTION/DROPS | ANDA077700 | f79d2ae4-ccfb-49ca-bf0e-e505f3477d30 |
| 2 | 174780106 | ANDA | Akorn | 2011-03-01 | LEVOFLOXACIN | OPHTHALMIC | SOLUTION | ANDA090268 | 6987500a-2feb-48a9-9d29-89693333a801 |
| 3 | 503830283 | ANDA | Hi-Tech Pharmacal Co., Inc. | 2011-02-10 | LEVOFLOXACIN | OPHTHALMIC | SOLUTION/DROPS | ANDA076826 | 2bc7f52d-05a5-4dc7-98a8-9412a2c53ea2 |
invalid application product(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 686690135 | Quixin | NDA | Vistakon Pharmaceuticals Llc | 2000-10-01 | LEVOFLOXACIN | OPHTHALMIC | SOLUTION | NDA021199 | 09b3a912-97f9-45ae-a162-9f45c860dc22 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA076826 | LEVOFLOXACIN | WATSON LABORATORIES INC | 2011-02-10 | ANDA076826_001 | |
| 2 | ANDA077700 | LEVOFLOXACIN | NEXUS PHARMACEUTICALS INC | 2010-12-20 | ANDA077700_001 | |
| 3 | ANDA078282 | LEVOFLOXACIN | True | APOTEX INC | 2010-12-20 | ANDA078282_001 |
| 4 | ANDA090268 | LEVOFLOXACIN | AKORN INC | 2010-12-20 | ANDA090268_001 | |
| 5 | NDA021199 | QUIXIN | True | SANTEN INC | 2000-08-18 | NDA021199_001 |
| 6 | NDA021571 | IQUIX | True | SANTEN INC | 2004-03-01 | NDA021571_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076826_001 | RX | LEVOFLOXACIN (0.5%) | OPHTHALMIC | SOLUTION/DROPS | False | AT | 2011-02-10 | LEVOFLOXACIN |
| 2 | ANDA077700_001 | RX | LEVOFLOXACIN (0.5%) | OPHTHALMIC | SOLUTION/DROPS | True | AT | 2010-12-20 | LEVOFLOXACIN |
| 3 | ANDA078282_001 | discontinued | LEVOFLOXACIN (0.5%) | OPHTHALMIC | SOLUTION/DROPS | False | 2010-12-20 | LEVOFLOXACIN | |
| 4 | ANDA090268_001 | RX | LEVOFLOXACIN (0.5%) | OPHTHALMIC | SOLUTION/DROPS | False | AT | 2010-12-20 | LEVOFLOXACIN |
| 5 | NDA021199_001 | discontinued | LEVOFLOXACIN (0.5%) | OPHTHALMIC | SOLUTION/DROPS | False | 2000-08-18 | QUIXIN | |
| 6 | NDA021571_001 | discontinued | LEVOFLOXACIN (1.5%) | OPHTHALMIC | SOLUTION/DROPS | False | 2004-03-01 | IQUIX |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 067ea8ec-99a3-4a0b-9116-4ffd6160b24b (view SPL) | IQUIX (levofloxacin ophthalmic solution) 1.5% | prescription | Human Prescription | Vistakon Pharmaceuticals Llc | 2010-03-18 | 3 | 686690145 | |
| 2 | 09b3a912-97f9-45ae-a162-9f45c860dc22 (view SPL) | QUIXIN (levofloxacin ophthalmic solution) 0.5% | prescription | Human Prescription | Vistakon Pharmaceuticals Llc | 2011-08-17 | 5 | 686690135 | |
| 3 | 2bc7f52d-05a5-4dc7-98a8-9412a2c53ea2 (view SPL) | Levofloxacin Ophthalmic Solution 0.05% | prescription | Human Prescription | Hi-Tech Pharmacal Co., Inc. | MANUFACTURE | 2012-09-06 | 4 | 503830283 |
| 4 | 6987500a-2feb-48a9-9d29-89693333a801 (view SPL) | Levofloxacin Ophthalmic Solution, 0.5% | prescription | Human Prescription | Akorn | ANALYSIS, MANUFACTURE, REPACK | 2010-12-31 | 2 | 174780106 |
| 5 | f79d2ae4-ccfb-49ca-bf0e-e505f3477d30 (view SPL) | prescription | Human Prescription | Pack Pharmaceuticals Llc | MANUFACTURE | 2011-05-04 | 3 | 165710150 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII