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 · 3 docket documents 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 The petitioner seeks this designation to permit futur | 505(q) | 2020-05-20 | Withdrawn | Hyman, Phelps & McNamara, P.C. |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 · 12 docket documents 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refuse to approve any ANDA for a generic version of Periostat (doxycycline hyclate) 20 mg capsules that was voluntarily withdrawn from | 505(q) Stay Request | 2018-03-29 | Granted | CollaGenex Pharmaceuticals, Inc |
Citizen Petition from CollaGenex Pharmaceuticals, Inc. FDA-2003-P-0008 · 12 docket documents 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 · 4 docket documents 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 · 3 docket documents 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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