BORTEZOMIB | N209191 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Gland Pharma Limited FDA-2021-P-0339 · 4 docket documents Gland Pharma Limited filed this citizen petition on March 22, 2021, requesting that the FDA determine whether Bortezomib for Injection in 1 mg/vial and 2.5 mg/vial strengths (NDA 209191), held by Hospira Inc., was voluntarily withdrawn from sale for reasons of safety or effectiveness, as required un | 505(q) | 2021-04-13 | Withdrawn | Gland Pharma Limited |
Citizen Petition from Fresenius Kabi USA, LLC FDA-2020-P-2130 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition on October 26, 2020, requesting that the FDA determine whether Hospira Inc voluntarily withdrew Bortezomib for Injection 2.5 mg/vial (NDA 209191) from sale for reasons of safety or effectiveness, as required under 21 CFR 314.161 before an ANDA refe | 505(q) | 2020-10-27 | Withdrawn | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.