GRISEOFULVIN, ULTRAMICROSIZE | A202545 | SIGMAPHARM LABORATORIES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2019-P-4261 · 4 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA designate an additional reference standard for Ultramicrocrystalline Griseofulvin Tablets, 250 mg, and amend the Orange Book to reflect ANDA 204371 held by Mountain LLC as a reference standard, because th | 505(q) | 2019-09-12 | Granted | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$3.93
per ea
Lowest NADAC/Unit
$2.95
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 42794001408GRISEOFULVIN ULTRA 250 MG TAB | $3.93 | EA | Generic | — | 2026-06-17 |
| 42794001308GRISEOFULVIN ULTRA 125 MG TAB | $2.95 | 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.