DOXYCYCLINE HYCLATE | N050783 | GALDERMA LABORATORIES LP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from CollaGenex Pharmaceuticals, Inc FDA-2002-P-0290 CollaGenex Pharmaceuticals, Inc. filed this citizen petition under sections 505(j)(2)(A) and 505(j)(7)(C) of the Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any ANDA for a generic version of Periostat (doxycycline hyclate) 20 mg capsules that was voluntarily withdrawn from | 505(q) Stay Request | 2018-03-29 | Granted | CollaGenex Pharmaceuticals, Inc |
Petition for Stay of Action from CollaGenex Pharmaceuticals, Inc. FDA-2002-P-0290 CollaGenex Pharmaceuticals, Inc. filed this July 2002 petition under 21 C.F.R. § 10.35 requesting a stay of action on any abbreviated new drug application (ANDA) for a generic version of Periostat (doxycycline hyclate) 20 mg capsules, which CollaGenex had voluntarily withdrawn from sale in 2001, pen | 505(q) Stay Request | 2018-03-29 | Granted | — |
Citizen Petition from CollaGenex Pharmaceuticals, Inc. FDA-2003-P-0008 CollaGenex Pharmaceuticals, Inc. filed this citizen petition under Section 505(j) of the Food, Drug, and Cosmetic Act requesting that FDA refuse to approve Mutual Pharmaceutical Company's ANDA for doxycycline hyclate tablets as a generic equivalent to CollaGenex's Periostat 20 mg tablets, arguing th | 505(q) | 2017-11-27 | Denied | CollaGenex Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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