MAGNESIUM SULFATE | N020488 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Andersen Pharma LLC FDA-2019-P-4979 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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