DOXYCYCLINE HYCLATE | A062475 | FRESENIUS KABI USA LLC
| 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 The petitioner seeks this designation to permit futur | 505(q) | 2020-05-20 | Withdrawn | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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