GABAPENTIN | A076017 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-0685 Hyman, Phelps & McNamara, P.C. filed this suitability petition under FDC Act Section 505(j)(2)(C) and 21 C.F.R. § 314.93 requesting that FDA declare Gabapentin Tablets, 300 mg, suitable for submission as an ANDA referencing Viatris Specialty LLC's NEURONTIN (gabapentin) Tablets approved under NDA 02 | Suitability | 2026-01-22 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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