HYDROCORTISONE ACETATE | N008917 | PHARMACIA AND UPJOHN CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Baker Hostetler, LLP FDA-2015-P-1090 · 7 docket documents Baker Hostetler LLP, on behalf of an unnamed client, filed this petition under 21 U.S.C. § 505 requesting that the FDA declare New Drug Application 17-351 for Cortifoam (hydrocortisone acetate) was not validly approved and should be withdrawn from the market because the application never satisfied s | Other | 2015-08-18 | Denied | Baker Hostetler, LLP |
Citizen Petition from Ferndale Laboratories, Inc. FDA-2001-P-0241 · 7 docket documents 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suitability for Hydrocortisone Acetate Lotion USP at 2.5% strength, which would differ from t | Other | 2011-04-05 | Withdrawn | Ferndale Laboratories, Inc. |
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drug application (ANDA) is suitable for Hydrocortisone Acetate Lotion USP 2.5%, using Hytone Lo | Other | 2011-02-09 | Withdrawn | Ferndale Laboratories, Inc. |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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