VANCOMYCIN HYDROCHLORIDE | A062476 | STERISCIENCE PTE LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Supplement from King & Spalding LLP FDA-2006-P-0344 King & Spalding LLP filed supplements to two suitability petitions for Vancomycin HCl USP 750 mg formulations in both Fliptop Vial and ADD-Vantage Vial presentations. The petitioner requested FDA approval under 21 U.S.C. § 355(j)(2)(C) to establish these intermediate-strength vials as suitable for a | Suitability | 2008-11-15 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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