ROBINUL

FDA-2023-P-4293 · 12 docket documents

Newcastle Bioscience, LLC filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA declare Glycopyrrolate Orally Disintegrating Tablets in strengths of 1 mg, 1.5 mg, and 2 mg suitable for submission as an ANDA, with the reference-listed drug being Robinul Forte (glycopyrrolate)

FDA-2022-P-1938 · 7 docket documents

Suven Pharmaceuticals Limited filed a suitability petition regarding glycopyrrolate tablets (Robinul and Robinul Forte) as reference-listed drugs under the ANDA pathway. The petition requests FDA confirmation of the appropriateness of these reference-listed drugs for use in abbreviated new drug appl

FDA-2022-P-1656 · 3 docket documents

Fresenius Kabi USA, LLC filed this citizen petition pursuant to 21 CFR 10.30 requesting that the FDA designate its Glycopyrrolate Injection, USP approved under 505(b)(2) NDA 214919 as therapeutically equivalent with an 'AP' rating to the reference listed drug Robinul® (NDA 017558) by Hikma Pharmaceu

FDA-2019-P-1678 · 4 docket documents

Exela Pharma Sciences, LLC filed this citizen petition requesting that the FDA assign a therapeutic equivalence code of "AP" to GLYRX-PF (glycopyrrolate injection) 0.2 mg/mL and 0.4 mg/2 mL, which was approved under NDA 210997, with respect to Somerset Therapeutics LLC's ANDA 207639 product for the

FDA-2018-P-4769 · 4 docket documents

Exela Pharma Sciences, LLC submitted this citizen petition pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA assign a therapeutic equivalence code of "AP" in the Orange Book for GLYRX-PF (glycopyrrolate injection) in strengths of 0.2 mg/mL and 0.4 mg/2

FDA-2018-P-1019 · 7 docket documents

Lachman Consultant Services Inc. filed this petition on behalf of a client pursuant to Section 505(j)(2)(C) requesting that the FDA declare Glycopyrrolate Injection in strengths of 0.6 mg/3 mL and 1.0 mg/5 mL in single dose prefilled syringes suitable for submission as an abbreviated new drug applic

FDA-2017-P-2869 · 7 docket documents

Lachman Consultant Services, Inc. submitted this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Glycopyrrolate Orally Disintegrating Tablets in strengths of 1 mg, 1.5 mg, and 2 mg suitable for submission as an ANDA, with

FDA-2016-P-1952 · 5 docket documents

Fresenius Kabi USA, LLC submitted this petition requesting that the FDA determine whether Robinul, Glycopyrrolate Injection (NDA 017558), held by Eurohealth International, was voluntarily withdrawn from sale for reasons of safety or efficacy, as required under 21 CFR 314.161 before ANDAs referring t

FDA-2014-P-0830 · 4 docket documents

Merz North America, through counsel Buchanan Ingersoll and Rooney PC, filed this citizen petition pursuant to sections 505(b)(1) and 505A of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner grant six-month pediatric exclusivity for Cuvposa (glycopyrrolate oral solution 1

FDA-2006-P-0147 · 4 docket documents

Lachman Consultant Services Inc. filed this citizen petition requesting that the FDA take action regarding glycopyrrolate products marketed under the proprietary names Robinul and Robinul Forte, specifically seeking clarification or regulatory action on the approved applications for these drug produ