HYDROCORTISONE | A080473 | VALEANT INTERNATIONAL BARBADOS SRL
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Ferndale Laboratories, Inc. FDA-2001-P-0054 · 4 docket documents Ferndale Laboratories, Inc. filed this petition on November 2, 2001, pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA determine that an abbreviated new drug application (ANDA) is suitable for Hydrocortisone Acetate Lotion USP 2.5%, using Hytone Lo | Other | 2011-02-09 | Withdrawn | Ferndale Laboratories, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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