OXCARBAZEPINE | N021014 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jubliant Generics Limited FDA-2017-P-7033 Jubilant Generics Limited submitted this petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting the FDA determine that Oxcarbazepine Oral Tablet 450 mg (dual scored) is suitable for consideration in an ANDA, with TRILEPTAL Tablets (150, 300, and 600 mg) under NDA 0 | Other | 2017-12-29 | Open | Jubliant Generics Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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