ARIPIPRAZOLE LAUROXIL | N209830 | ALKERMES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Otsuka Pharmaceutical Company Ltd., (Otsuka Pharmaceuti... FDA-2014-P-1354 · 4 docket documents Otsuka Pharmaceutical Development & Commercialization, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refuse to accept for substantive review an NDA submitted by Alkermes plc for aripiprazole lauroxil, arguing that the applicatio | 505(q) | 2014-09-11 | Denied | Otsuka Pharmaceutical Company Ltd., (Otsuka Pharmaceutical Development & Commercialization, Inc.) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1026.91
per ml
Lowest NADAC/Unit
$1026.91
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 65757050003ARISTADA INITIO ER 675 MG/2.4 | $1026.91 | ML | Brand | — | 2026-01-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.