NEURONTIN

FDA-2026-P-2258 · 7 docket documents

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-2025-P-0411 · 7 docket documents

Premier Consulting, through Director of Regulatory Affairs Seth D. DePuy, submitted an ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that Gabapentin 200mg Capsules is suitable for submission in an Abbreviated New Dr

FDA-2023-P-4876 · 9 docket documents

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 · 7 docket documents

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-2022-P-0149 · 9 docket documents

Public Citizen submitted this petition on February 9, 2022, under Section 201 of the Controlled Substances Act and FDA regulations requesting that the DEA and FDA initiate proceedings to schedule gabapentin (brand names Neurontin and Gralise) and gabapentin enacarbil (brand name Horizant) into Sched

FDA-2001-P-0445 · 3 docket documents

Apotex Corp. filed this citizen petition on behalf of its affiliate TorPharm Division, requesting that the FDA determine that the three-day titration dosing schedule for Neurontin capsules (gabapentin) was not withdrawn for safety or effectiveness reasons and therefore allow TorPharm's pending ANDA

FDA-1999-P-0125 · 4 docket documents

Palmer & Dodge LLP filed this citizen petition under section 505(q) of the FD&C Act requesting that FDA's Office of Generic Drugs refuse to accept for filing any ANDA for gabapentin tablets that uses Neurontin capsules as the reference product in bioequivalence studies, arguing that such application

FDA-2000-P-0409 · 3 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on June 22, 2000, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA determine that an Abbreviated New Drug Application may be submitted for Gabapentin Tablets in strengths of 100 mg, 300

FDA-2000-P-0001 · 5 docket documents

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-1999-P-2947 · 3 docket documents

Lachman Consultant Services, Inc., filed this citizen petition on behalf of Purepac Pharmaceutical Co. requesting that the FDA determine whether Parke-Davis's Neurontin (Gabapentin) Tablets in 600 mg and 800 mg strengths (NDA-20-882) were voluntarily withdrawn from sale for safety or effectiveness r

FDA-2004-P-0014 · 3 docket documents

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