FLUDROCORTISONE ACETATE | A040431 | IMPAX LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Rising Pharma Holdings, Inc FDA-2024-P-4514 · 10 docket documents Rising Pharma Holdings, Inc. filed a suitability petition under 21 CFR 314.93 requesting FDA approval to submit an Abbreviated New Drug Application for Fludrocortisone Acetate Tablets in 0.05 mg and 0.2 mg strengths, which differ from the reference listed drug Florinef (0.1 mg) and reference standar | Suitability | 2024-09-25 | Granted | Rising Pharma Holdings, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.3206
per ea
Lowest NADAC/Unit
$0.3206
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00115703301FLUDROCORTISONE 0.1 MG TABLET | $0.3206 | EA | Generic | — | 2026-06-17 |
| 00115703302FLUDROCORTISONE 0.1 MG TABLET | $0.3206 | EA | Generic | — | 2026-06-17 |
| 50268033015FLUDROCORTISONE 0.1 MG TABLET | $0.3206 | EA | Generic | — | 2026-06-17 |
| 68084028801FLUDROCORTISONE 0.1 MG TABLET | $0.3206 | EA | Generic | — | 2026-06-17 |
| 68084028865FLUDROCORTISONE 0.1 MG TABLET | $0.3206 | 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.