LORATADINE | N019658 | BAYER HEALTHCARE LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Blue Cross of California - Citizen Petition FDA-1998-P-0254 · 3 docket documents Blue Cross of California, filed under 21 CFR 10.30, petitioned the FDA to convert six prescription antihistamine medications—Allegra, Allegra-D, Claritin, Claritin-D, Claritin-D 24 Hour, and Zyrtec—to over-the-counter status, arguing these selective antihistamines are safer than currently available | Other | 2009-04-30 | Open | — |
Citizen Petition from Strides, Inc. FDA-2006-P-0087 · 4 docket documents Strides, Inc. filed this citizen petition requesting that the FDA take action regarding loratadine products, specifically concerning the Orange Book listings and regulatory status of various loratadine formulations including tablets, syrups, and suspensions marketed under names such as Claritin and | Other | 2009-04-20 | Denied | Strides, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0015 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of MonoSolRx, LLC pursuant to section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Loratadine Orally-Dissolving Strips in 5 mg and 10 mg strengths suitable for consideration in an abbr | Other | 2008-04-11 | Open | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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