DOXYCYCLINE | N050006 | PFIZER LABORATORIES DIV PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Strides Pharma Inc. FDA-2025-P-0100 · 4 docket documents Strides Pharma Inc. filed this citizen petition requesting that the FDA determine whether Pfizer's Reference Listed Drug Vibramycin doxycycline oral suspension 25 mg base per 5 mL, approved under NDA 050006, was voluntarily withdrawn from sale for safety or efficacy reasons, as the product currently | 505(q) | 2025-01-10 | Granted | Strides Pharma Inc. |
Petition for Stay of Action from CollaGenex Pharmaceuticals, Inc. FDA-2002-P-0290 · 12 docket documents 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(ANDA) for a generic version of Periostat (doxycycline hyclate) 20 mg capsules, which CollaGenex had voluntarily withdrawn from sale in 2001, pen | 505(q) Stay Request | 2018-03-29 | Granted | — |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 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 | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0341 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Doxycycline Monohydrate Tablets, 125 mg, suitable for submission in an abbreviated new drug application, using Adoxa Tabl | Other | 2009-01-08 | Open | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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