CARVEDILOL PHOSPHATE | A204717 | IMPAX LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Keller And Heckman LLP FDA-2007-P-0058 · 11 docket documents Keller and Heckman LLP filed this suitability petition under Section 505(j)(2)(C) requesting FDA approval to file an ANDA for carvedilol phosphate in extended-release tablet form, which would differ from the reference listed drug Coreg CR (carvedilol phosphate extended-release capsules) only in dosa | Other | 2008-07-10 | Withdrawn | Keller And Heckman LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$6.67
per ea
Lowest NADAC/Unit
$5.63
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00115124808CARVEDILOL ER 10 MG CAPSULE | $6.67 | EA | Generic | — | 2026-06-17 |
| 00115125008CARVEDILOL ER 40 MG CAPSULE | $6.61 | EA | Generic | — | 2026-06-17 |
| 00115124908CARVEDILOL ER 20 MG CAPSULE | $6.49 | EA | Generic | — | 2026-06-17 |
| 00115125108CARVEDILOL ER 80 MG CAPSULE | $5.63 | EA | 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.