FORMOTEROL FUMARATE | N022007 | VIATRIS SPECIALITY LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from K&L Gates LLP FDA-2023-P-2536 · 4 docket documents K&L Gates LLP filed this petition on behalf of an unnamed client requesting that the FDA determine whether FORADIL (Formoterol fumarate) Inhalation Powder, 0.012 mg/inh approved under NDA N020831 was withdrawn for safety or effectiveness reasons under Section 505(w) of the FDC Act and 21 C.F.R. § 31 | 505(q) | 2023-06-22 | Granted | K&L Gates LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$10.12
per ml
Lowest NADAC/Unit
$1.19
per ml
Brand NDCs
2
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 49502060561PERFOROMIST 20 MCG/2 ML SOLN | $10.12 | ML | Brand | $1.31 | 2026-01-01 |
| 49502060530PERFOROMIST 20 MCG/2 ML SOLN | $10.05 | ML | Brand | $1.19 | 2026-01-01 |
| 00378163191FORMOTEROL 20 MCG/2 ML NEB VL | $1.31 | ML | Generic | — | 2026-06-17 |
| 00378163193FORMOTEROL 20 MCG/2 ML NEB VL | $1.19 | 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.