NEOSTIGMINE METHYLSULFATE

FDA-2022-P-0287 · 3 docket documents

Fresenius Kabi USA, LLC filed this petition requesting that the FDA designate its Neostigmine Methylsulfate Injection, approved under 505(b)(2) NDA 203629, as therapeutically equivalent with an AB rating to the reference listed drug Bloxiverz (NDA 204078). The petitioner argues that its product is p

FDA-2021-P-0277 · 2 docket documents

Lachman Consulting Services Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Neostigmine Methylsulfate Injection in three new strengths (5 mg/5 mL, 1.5 mg/3 mL, and 2.5 mg/5 mL single-dose prefilled syringes) suitable for submission as a

FDA-2020-P-0947 · 4 docket documents

Hyman, Phelps and McNamara, P.C. submitted this citizen petition pursuant to Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA amend the Orange Book to designate Neostigmine Methylsulfate Injection Solution, approved under NDA 203629, as both a Reference Listed Drug a

FDA-2019-P-1636 · 7 docket documents

Nexsen Pruet, LLC filed this citizen petition on April 4, 2019, under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Neostigmine Methylsulfate Injection, Solution 3 mg/3 mL (1 mg/mL), NDA No. 203629, as a Reference Listed Drug to enable the submission of