LEVETIRACETAM | N021872 | UCB INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jubilant Generics Limited FDA-2017-P-0115 Jubilant Generics Limited filed this citizen petition pursuant to section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act and 21 CFR section 314.93 requesting FDA determination that Levetiracetam Injection 1000 mg/10 mL and 1500 mg/15 mL are suitable for submission in an ANDA, using Keppra I | Other | 2017-01-06 | Withdrawn | Jubilant Generics Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.