NEURONTIN

FDA-2026-P-2258

Lachman Consulting Services, Inc., on behalf of a client, filed this suitability petition pursuant to Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Gabapentin Powder for Oral Solution in 300 mg/sachet, 400 mg/sachet, and 600 mg/sachet strengths suitable for submission as an AN

FDA-2023-P-4876

Strides Pharma Inc. filed a suitability petition regarding approved labeling for Neurontin tablets, likely seeking FDA confirmation that the established labeling is suitable as a reference standard for an abbreviated new drug application or generic drug development.

FDA-2023-P-4876

Strides Pharma Inc. filed a petition regarding the Orange Book entry for NEURONTIN Tablets, specifically seeking a determination about the suitability of an abbreviated new drug application pathway for a generic gabapentin product. The petition challenges the existing Orange Book listing to facilita

FDA-2023-P-4658

Hyman, Phelps & McNamara, P.C. filed a petition regarding the suitability of prescribing information for Neurontin (gabapentin) capsules, though the specific regulatory action requested and detailed arguments are not provided in this document excerpt.

FDA-2000-P-0001

Pfizer Inc submitted a citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA issue non-approvable letters to generic drug manufacturers who failed to comply with patent certification and notification requirements under 21 USC 355(j)(2)(A)(vii) for abbreviated new drug applications re

FDA-2004-P-0014

Pfizer Inc. filed this citizen petition under sections 505(b) and (i) of the Federal Food, Drug and Cosmetic Act requesting that the FDA adhere to the statutory limitations of section 505(j)(5)(B)(iv) regarding the 180-day exclusivity period for ANDA applicants, specifically asking the FDA to deny a