DOXYCYCLINE HYCLATE | N205931 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Apotex Inc. FDA-2014-P-1930 Apotex Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate Acticlate (Doxycycline Hyclate, 150mg Base), subject of NDA 205931 held by Aqua Pharms LLC, as a reference listed drug to enable Apotex to submit an ANDA for a ge | 505(q) | 2014-11-14 | Withdrawn | Apotex Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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