VANCOMYCIN HYDROCHLORIDE | A062682 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hospira FDA-2015-P-3621 Hospira filed this ANDA suitability petition under section 505(j)(2)(C) requesting that the FDA determine that Vancomycin Hydrochloride for Injection, USP 10 gram pharmacy bulk package is suitable for ANDA submission and that the discontinued reference listed drug VANCOLED 10G pharmacy bulk package | Other | 2015-11-06 | Denied | Hospira |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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