DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | N011265 | ANI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Windels Marx Lane & Mittendorf, LLP FDA-2020-P-1771 · 3 docket documents Windels Marx Lane & Mittendorf, LLP filed this citizen petition requesting that the FDA designate Dextromethorphan Hydrobromide and Promethazine Hydrochloride Oral Syrup (15 mg/5 mL; 6.25 mg/5 mL) approved under ANDA 088864 as a new reference standard in the Orange Book because the current reference | 505(q) | 2020-08-19 | Withdrawn | Windels Marx Lane & Mittendorf, LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0383
per ml
Lowest NADAC/Unit
$0.0383
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 62559075816PROMETHAZINE-DM 6.25-15 MG/5 ML SOLUTION | $0.0383 | 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.