VERAPAMIL HYDROCHLORIDE | N019038 | GD SEARLE LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from AuroMedics Pharma LLC (Aurobindo Pharma Limited) FDA-2017-P-2460 AuroMedics Pharma LLC, on behalf of Aurobindo Pharma Limited, filed a citizen petition on April 18, 2017 requesting that the FDA determine the discontinuation of NDA 019038 for CALAN (verapamil hydrochloride) Injection, 2.5 mg/mL was not due to safety and efficacy reasons, and designate this NDA as | 505(q) | 2017-04-19 | Withdrawn | AuroMedics Pharma LLC (Aurobindo Pharma Limited) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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