NIMODIPINE | N203340 | AZURITY PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Windels Marx Lane & Mittendorf, LLP FDA-2020-P-1549 · 6 docket documents Windels Marx Lane & Mittendorf, LLP filed this petition on behalf of a client requesting that the FDA determine whether Nymalize (Nimodipine) Oral Solution 3 mg/mL under NDA 203340 held by Arbor Pharmaceuticals LLC was voluntarily withdrawn for safety or effectiveness reasons. The petitioner asserts | 505(q) | 2020-06-16 | Granted | Windels Marx Lane & Mittendorf, LLP |
Citizens Petition from Annora Pharma Private Limited FDA-2020-P-1511 · 10 docket documents Annora Pharma Private Limited filed this citizen petition requesting that the FDA Commissioner determine whether Arbor Pharmaceuticals LLC voluntarily withdrew NYMALIZE (nimodipine) oral solution 3 mg/mL (NDA 203340) for reasons other than safety or effectiveness, citing that the company replaced it | 505(q) | 2020-06-08 | Granted | Annora Pharma Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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