FLUDROCORTISONE ACETATE | A040431 | IMPAX LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Rising Pharma Holdings, Inc. FDA-2024-P-4514 Rising Pharma Holdings, Inc. filed this amendment to suitability petition FDA-2024-P-4514 to seek permission to file an ANDA for Fludrocortisone Acetate Tablets in 0.05 mg, 0.1 mg, and 0.2 mg strengths. The amendment provides proposed product labeling (package inserts) in response to the FDA's Octob | Suitability | 2024-10-10 | Granted | Rising Pharma Holdings, Inc. |
Suitability Petition from Rising Pharma Holdings, Inc FDA-2024-P-4514 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
$0.3160
per ea
Lowest NADAC/Unit
$0.3160
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00115703301FLUDROCORTISONE 0.1 MG TABLET | $0.3160 | EA | Generic | — | 2026-10-21 |
| 00115703302FLUDROCORTISONE 0.1 MG TABLET | $0.3160 | EA | Generic | — | 2026-10-21 |
| 50268033015FLUDROCORTISONE 0.1 MG TABLET | $0.3160 | EA | Generic | — | 2026-10-21 |
| 68084028801FLUDROCORTISONE 0.1 MG TABLET | $0.3160 | EA | Generic | — | 2026-10-21 |
| 68084028865FLUDROCORTISONE 0.1 MG TABLET | $0.3160 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.