HYDROCORTISONE ACETATE | A040396 | LEGACY PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Ferndale Laboratories, Inc. FDA-2001-P-0241 Ferndale Laboratories, Inc. filed this citizen petition on August 10, 2001, pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA make a determination of ANDA suitability for Hydrocortisone Acetate Lotion USP at 2.5% strength, which would differ from t | Other | 2011-04-05 | Open | Ferndale Laboratories |
Citizen Petition from Ferndale Laboratories, Inc. FDA-2001-P-0054 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 | Open | Ferndale Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.