MAGNESIUM SULFATE | N020488 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Andersen Pharma LLC FDA-2019-P-4979 · 5 docket documents Andersen Pharma LLC submitted this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine Magnesium Sulfate in 5% Dextrose Injection, USP, 1 gm/50 mL is suitable for submission in an ANDA, with the only change from the reference | Other | 2019-10-28 | Open | Andersen Pharma LLC |
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 | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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