NEOSTIGMINE METHYLSULFATE | N204078 | EXELA PHARMA SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC 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 | Other | 2022-03-04 | Open | Fresenius Kabi USA, LLC |
Citizen Petition from King & Spalding LLP FDA-2017-P-6116 · 6 docket documents King & Spalding LLP filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Neostigmine Methylsulfate Injection, USP in strengths of 2 mg/2 mL, 3 mg/3 mL, 4 mg/4 mL, and 5 mg/5 mL suitable for submission in an ANDA, with | Other | 2017-10-12 | Partially Denied | King & Spalding LLP |
Eclat Pharmaceuticals, LLC (Patton Boggs LLP) - Citizen Petition FDA-2013-P-1000 · 3 docket documents Eclat Pharmaceuticals, LLC, through counsel Patton Boggs LLP, filed this citizen petition requesting that the FDA take expedited enforcement action to remove unapproved injectable neostigmine methylsulfate products marketed by Cardinal Health, West-Ward Pharmaceuticals, Fresenius Kabi USA, American | Other | 2013-09-04 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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