LEVORPHANOL TARTRATE | A074278 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1-Orange Book re: Suitability Petition from Nostrum Laboratories, ... FDA-2023-P-4617 · 7 docket documents Nostrum Laboratories, Inc. filed a petition requesting FDA confirmation that generic versions of levorphanol tartrate oral solutions are suitable for abbreviated new drug application (ANDA) approval, seeking to establish bioequivalence to reference products and clarify the regulatory pathway for thi | Suitability | 2023-10-24 | Denied | Nostrum Laboratories, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$10.65
per ea
Lowest NADAC/Unit
$10.65
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00054043825LEVORPHANOL 2 MG TABLET | $10.65 | EA | Generic | — | 2026-02-18 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.