MICAFUNGIN SODIUM | N212125 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment2_Draft Insert Labeling for Proposed Micafungin Sodium for Injectio... FDA-2017-P-6451 Locke Lord LLP filed a suitability petition regarding proposed Micafungin Sodium for Injection in 50 mg, 100 mg, and 150 mg strengths, requesting FDA evaluation of the appropriateness of the proposed drug formulation and labeling for regulatory approval under the new drug application pathway. | Suitability | 2017-11-09 | Open | Locke Lord LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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