SEVOFLURANE | N020478 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Emprise Pharma LLC on behalf of Shandong New Time P... FDA-2026-P-3840 Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co., Ltd filed a suitability petition under section 505(j)(2)(C) of the FD&C Act requesting approval to add a 100 mL bottle presentation to the already approved ANDA 214382 for sevoflurane inhalation liquid, which is currently approved | Suitability | 2026-04-10 | Open | Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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