MAGNESIUM SULFATE | A202411 | HOSPIRA INC
| 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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