MECLIZINE HYDROCHLORIDE | N010721 | CASPER PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceutical (USA) Inc FDA-2016-P-1667 Zydus Pharmaceuticals (USA) Inc. filed this citizen petition requesting that the FDA determine whether ANTIVERT (Meclizine Hydrochloride) Tablets, 12.5 mg and 25 mg approved under NDA 010721 by Casper Pharma LLC. was voluntarily withdrawn for safety or effectiveness reasons, and if not, to designate | 505(q) | 2016-06-16 | Denied | Zydus Pharmaceutical (USA) Inc |
Citizen Petition from Lupin Pharmaceuticals, Inc. FDA-2015-P-3400 Lupin Pharmaceuticals, Inc. filed this citizen petition requesting that FDA determine whether Citron Pharma LLC voluntarily withdrew, discontinued, or withheld from sale ANTIVERT (Meclizine Hydrochloride) Tablets in 12.5 mg, 25 mg, and 50 mg strengths under NDA 010721, and if so, whether generic ver | Other | 2015-09-23 | Denied | Lupin Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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