LEVETIRACETAM | N021872 | UCB INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jubilant Generics Limited FDA-2017-P-0115 · 7 docket documents 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Injection 1000 mg/10 mL and 1500 mg/15 mL are suitable for submission in an ANDA, using Keppra I | Other | 2017-01-06 | Withdrawn | Jubilant Generics Limited |
Nexus Pharmaceuticals, Inc. - Citizen Petition FDA-2011-P-0186 · 5 docket documents Nexus Pharmaceuticals, Inc. filed this suitability petition requesting that the FDA declare Levetiracetam Injection 1000 mg/Vial suitable for submission as an Abbreviated New Drug Application under section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act, with the reference listed drug being | Other | 2011-04-04 | Open | — |
The Weinberg Group, Inc. - Citizen Petition FDA-2009-P-0285 · 5 docket documents The Weinberg Group Inc. filed a suitability petition on June 19, 2009, requesting that the FDA declare Levetiracetam Extended-Release Tablets in 1000 mg and 1500 mg strengths suitable for submission as an ANDA, with the reference listed drug being Keppra XR 750 mg approved under NDA 22-285, arguing | Other | 2009-06-23 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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