AMIKACIN SULFATE | A063315 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Qilu Pharma, Inc. FDA-2015-P-0613 · 4 docket documents 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, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.27
per ml
Lowest NADAC/Unit
$2.27
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00641616710AMIKACIN SULF 500 MG/2 ML VIAL | $2.27 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.