DOXYCYCLINE HYCLATE | N050442 | PFIZER LABORATORIES DIV PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2020-P-1403 The law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA designate Doxycycline Hyclate for Injection (100 mg and 200 mg base per vial) approved under ANDA 062475 as reference listed drugs in the Orange Book. The petitioner seeks this designation to permit futur | 505(q) | 2020-05-20 | Withdrawn | Hyman, Phelps & McNamara, P.C. |
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refuse to approve any ANDA for a generic version of Periostat (doxycycline hyclate) 20 mg capsules that was voluntarily withdrawn from | 505(q) Stay Request | 2018-03-29 | Granted | CollaGenex Pharmaceuticals, Inc |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(ANDA) for a generic version of Periostat (doxycycline hyclate) 20 mg capsules, which CollaGenex had voluntarily withdrawn from sale in 2001, pen | 505(q) Stay Request | 2018-03-29 | Granted | — |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. |
Citizen Petitions from Mayne Pharma lnternational Pty Ltd FDA-2016-P-4047 Mayne Pharma International Pty Ltd filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require specific in vitro dissolution criteria for any ANDA referencing Doryx MPC (doxycycline hyclate delayed-release tablets), the company's refer | 505(q) | 2016-11-28 | Open | — |
Warner Chilcott, LLC and Mayne Pharmaceuticals International Pty Ltd. - Citiz... FDA-2011-P-0702 Warner Chilcott, LLC and Mayne Pharmaceuticals International Pty Ltd., the U.S. agent and sponsor respectively of Doryx (doxycycline hyclate delayed-release tablets) NDA 50-795, filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refra | 505(q) | 2011-09-27 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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