MAGNESIUM SULFATE | N019316 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA LLC FDA-2018-P-3933 · 3 docket documents Fresenius Kabi USA, LLC filed this petition requesting that the FDA designate Hospira, Inc's Magnesium Sulfate Injection, USP, 10 gm/10 mL, approved under ANDA 202411, as therapeutically equivalent with an 'AP' rating to Fresenius Kabi's reference listed drug Magnesium Sulfate Injection, USP, 10 gm/ | 505(q) | 2018-10-17 | Granted | Fresenius Kabi USA LLC |
Sheppard, Mullin, Richter & Hampton LLP - Citizen Petition FDA-2012-P-0997 · 3 docket documents Sheppard, Mullin, Richter & Hampton LLP filed this citizen petition on September 14, 2012, requesting that the FDA declare Magnesium Sulfate Injection, USP 50%, in 2 mL and 10 mL glass vials suitable for submission under an Abbreviated New Drug Application (ANDA). The petitioner seeks approval for a | Other | 2012-09-26 | Withdrawn | — |
Sheppard, Mullin, Richter & Hampton LLP - Citizen Petition FDA-2012-P-1004 · 3 docket documents Sheppard Mullin, Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Magnesium Sulfate Injection, USP 50% in a 50 mL glass vial suitable for submission and review pursuant to an ANDA, with t | Other | 2012-09-26 | Withdrawn | — |
Olson Frank Weeda Terman Bode Matz, PC - Citizen Petition FDA-2009-P-0397 · 6 docket documents The law firm Olsson Frank Weeda Terman Bode Matz PC filed an ANDA suitability petition on August 18, 2009, requesting FDA approval under Section 505(j)(2)(C) of the FDC Act to find that magnesium sulfate injection, USP, 50% solution in 20 mL and 50 mL fill volumes, is suitable for submission in an a | Other | 2009-09-01 | Granted | — |
APP Pharmaceuticals - Citizen Petition FDA-2009-P-0091 · 3 docket documents APP Pharmaceuticals filed this citizen petition regarding magnesium sulfate injection USP, requesting that the FDA take action concerning NDA 019316, which was originally approved on September 8, 1986 for Abraxis Pharm's magnesium sulfate injection 500 mg/mL formulation. The specific requested actio | Other | 2009-02-26 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.