POLYMYXIN B SULFATE | A060716 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2019-P-5441 · 6 docket documents On November 18, 2019, the law firm Hyman, Phelps & McNamara, P.C., filed a citizen petition requesting that the FDA designate ANDA 202766 (Polymyxin B Sulfate Injection, EQ 500,000 units base/vial, held by Xellia Pharmaceuticals APS) as a new reference standard in the Orange Book because the current | 505(q) | 2019-11-19 | Withdrawn | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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