AMIKACIN SULFATE | A064045 | MEITHEAL PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Qilu Pharma, Inc. FDA-2015-P-0613 Qilu Pharma, Inc., as the US Agent of Qilu Pharmaceutical Co., Ltd., submitted this petition on February 25, 2015, requesting that the FDA designate the Amikacin sulfate injection (EQ 250mg BASE/ML) from Teva Parenteral Medicines, Inc., with ANDA application 064045, as a new or alternative reference | 505(q) | 2015-02-26 | Partially Denied | Qilu Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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