DOXYCYCLINE HYCLATE | N050582 | MAYNE PHARMA INTERNATIONAL PTY LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 | — |
Lachman Consultant Services Inc. - Citizen Petition FDA-2004-P-0475 · 3 docket documents Lachman Consultant Services Inc. filed this citizen petition on behalf of an unnamed client on August 31, 2004, requesting that the FDA declare doxycycline hyclate tablets at 75 mg and 100 mg strengths suitable for submission in an abbreviated new drug application (ANDA), with Doryx capsules (coated | Other | 2010-03-12 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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