ARGATROBAN | N206769 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Comodo Health, Inc. FDA-2015-P-2736 Comodo Health, Inc. filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that FDA determine the suitability of Argatroban in Sodium Chloride Injectable for intravenous use in three different vial fill sizes (25 mg/25 mL, 50 mg/50 mL, and 100 mg/100 mL) compared to the reference lis | Suitability | 2015-08-04 | Open | Comodo Health |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.