VANCOMYCIN HYDROCHLORIDE | A062933 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hospira, Inc. FDA-2024-P-2085 Hospira, Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that Vancomycin Hydrochloride for Injection, USP, ADD-Vantage® Vial, 1.25 grams (base)/vial is suitable for submission as an additional strength und | Suitability | 2024-04-26 | Open | Hospira |
Citizen Petition from Hospira Inc., a Pfizer Company FDA-2022-P-0535 Hospira Inc., a Pfizer Company, filed this citizen petition pursuant to Section 505(j)(2)(C) of the FDC Act requesting that FDA determine an additional strength of Vancomycin Hydrochloride for Injection, USP, ADD-Vantage® Vial, 1.25 grams (base) per vial, is suitable for submission and review as an | Other | 2022-04-06 | Withdrawn | Hospira Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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