MICAFUNGIN SODIUM | N212125 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment3_Labeling of the Approved Product, Mycamine® for Injection ) re: S... FDA-2017-P-6451 The law firm Locke Lord LLP filed a petition regarding the labeling of Mycamine for Injection, an approved antifungal drug product. The petition addresses issues related to the product's labeling and its suitability, though the specific requested regulatory action is not detailed in the provided tex | Suitability | 2017-11-09 | Granted | Locke Lord LLP |
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 | Granted | Locke Lord LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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