DOXYCYCLINE HYCLATE | A062653 | WARNER CHILCOTT BERMUDA 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 | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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