MAGNESIUM SULFATE | N020309 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consultant Services, Inc. FDA-2024-P-0667 · 13 docket documents Lachman Consultant Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Magnesium Sulfate in Water for Injection, 3 g/100 mL (30 mg/mL) suitable for submission in an ANDA under Section 505(j)(2)(C) of the FD&C Act, with the reference listed drug being | Suitability | 2024-02-06 | Granted | Lachman Consultant Services, Inc. |
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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