NEURONTIN

FDA-2026-P-5123

Rising Pharma Holdings, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the FDC Act requesting FDA approval to submit an Abbreviated New Drug Application for Gabapentin Capsules 150 mg, a new strength that differs from the reference listed drug Neurontin capsules (100 mg, 30

FDA-2025-P-0375

Pharmobedient Consulting, LLC filed a suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Gabapentin Capsules 200 mg suitable for submission in an Abbreviated New Drug Application, with the Reference Listed Drug being NEUR

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

The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Gabapentin Capsules in 450 mg, 600 mg, and 800 mg strengths suitable for submission as an Abbrevia

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