METHYLPHENIDATE | N205489 | NEOS THERAPEUTICS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Neos Therapeutics, Inc. et al v. Teva Pharmaceuticals USA, Inc. 3 patentsANDA 210924methylphenidate | D. Del. | 2017-12-13 | Terminated 2019-01-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
| Other | 2012-04-12 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
NEOS THERAPEUTICS' METHYLPHENIDATE COTEMPLA XR-ODT (NDA 205489, Supplement 002) received an AB therapeutic equivalence rating, allowing generic substitution.
New: AB
Neos Therapeutics' COTEMPLA XR-ODT (methylphenidate) received a therapeutic equivalence code of AB, permitting generic substitution.
New: AB
COTEMPLA XR-ODT (methylphenidate) received an AB therapeutic equivalence code, indicating FDA approval as therapeutically equivalent to the reference product.
New: AB