NEURONTIN

FDA-2026-P-5611

Senores Pharmaceuticals, Inc. 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 Tablets 150 mg suitable for submission in an Abbreviated New Drug Application (ANDA). The petition seeks approval to deve

FDA-2025-P-6525

Senores Pharmaceuticals, Inc. filed a withdrawal request on January 29, 2026, for its ANDA suitability petition (FDA-2025-P-6525) seeking declaration that Gabapentin Tablets 200 mg is suitable for submission in an ANDA based on NDA 020882 for Neurontin. The company requested withdrawal after the FDA

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

FDA-2025-P-6525

Senores Pharmaceuticals, Inc. filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Gabapentin Tablets 200 mg, a new strength based on the Reference Listed Drug Neurontin (approved

FDA-2023-P-4876

Strides Pharma Global Pte. Ltd. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Gabapentin Tablets USP, 200 mg suitable for submission as an Abbreviated New Drug Application, with the

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