MOXIFLOXACIN HYDROCHLORIDE | N021598 | HARROW EYE LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Alcon Pharmaceuticals Ltd. et al v. Akorn, Inc. 2 patentsANDA 021598moxifloxacin hydrochloride | D. Del. | 2015-10-21 | Terminated 2015-11-13 | — |
Alcon Pharmaceuticals Ltd et al v. Apotex Inc. et al 2 patentsANDA 90080moxifloxacin hydrochloride | D. Del. | 2012-07-20 | Terminated 2013-12-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from RegCon Solutions, LLC FDA-2023-P-4337 RegCon Solutions, LLC filed this suitability petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Moxifloxacin hydrochloride ophthalmic solution 0.5% in unit-dose form (0.4 mL fill volume) suitable for submission as an ANDA, with the reference lis | Suitability | 2023-10-04 | Open | RegCon Solutions |
Suitability Petition from Regcon Solutions FDA-2022-P-3046 Regcon Solutions submitted a suitability petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Moxifloxacin hydrochloride ophthalmic solution 0.5% in unit-dose format (0.4 mL fill volume) suitable for submission as an abbreviated new drug applicati | Suitability | 2022-12-01 | Open | Regcon Solutions |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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