VANCOMYCIN HYDROCHLORIDE | A062933 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hospira, Inc. FDA-2024-P-2085 · 7 docket documents 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 | Denied | Hospira, Inc. |
Citizen Petition from Hospira Inc., a Pfizer Company FDA-2022-P-0535 · 6 docket documents 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USP, ADD-Vantage® Vial, 1.25 grams (base) per vial, is suitable for submission and review as an | Other | 2022-04-06 | Withdrawn | Hospira Inc., a Pfizer Company |
Citizen Petition from FDA CDER to King and Spalding, LLP FDA-2006-P-0146 · 5 docket documents This document contains Orange Book database records for vancomycin hydrochloride injectable approved under NDA 062933 to Hospira, showing no unexpired patents or exclusivity protections as of December 2006. The records do not constitute an actual citizen petition but rather appear to be regulatory s | Other | 2008-11-15 | Granted | FDA CDER to King and Spalding, LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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