VERAPAMIL HYDROCHLORIDE | N019152 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Heritage Pharma, Inc. FDA-2016-P-2674 Heritage Pharma, Inc., acting as the U.S. agent for Emcure Pharmaceuticals Limited, filed this citizen petition on August 31, 2016, requesting that the FDA determine that Pfizer's discontinuation of CALAN SR 180 mg Tablets (NDA 019152) was not due to safety and efficacy reasons, to permit Emcure to | 505(q) | 2016-09-09 | Withdrawn | Heritage Pharma |
Citizen Petition from Heritage Pharma Labs Inc FDA-2015-P-2141 Heritage Pharma Labs Inc filed this citizen petition under 21 U.S.C. § 355(j)(2)(c) requesting that the FDA immediately designate an alternative reference listed drug for verapamil hydrochloride extended release tablets 180 mg to replace the currently designated RLD, CALAN SR 180 mg, due to its unav | 505(q) | 2015-06-15 | Denied | Heritage Pharma Labs Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.