AMPHETAMINE | N204326 | NEOS THERAPEUTICS
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Aytu BioPharma, Inc. et al v. Granules Pharmaceuticals Inc. 4 patentsANDA 219800amphetamine | D. Del. | 2024-12-11 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Exhibit G Final Clinical Study Report Protocol No 381.103 Mixed Salts Ampheta... FDA-2005-P-0120 Shire Pharmaceuticals Group filed a citizen petition requesting FDA review and approval of bioequivalence and bioavailability data for SLI381, a 30 mg mixed salts amphetamine extended-release capsule formulation (IND 58,037). The petition sought to establish that SLI381 administered sprinkled on app | 505(q) | 2012-04-12 | Denied | — |
Exhibit H Final Clinical Study Report Protocol No 381.107 Mixed Salts Ampheta... FDA-2005-P-0120 Shire Pharmaceuticals Group filed a citizen petition in support of a new drug application for SLI381, a mixed salts amphetamine extended-release formulation for attention deficit hyperactivity disorder. The petition included a clinical study demonstrating bioequivalence between a single 40 mg capsul | Other | 2012-04-12 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.