DAPSONE | A086842 | EVEREST LIFE SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Macleods Pharmaceuticals Limited FDA-2024-P-5379 · 7 docket documents Macleods Pharmaceuticals Limited submitted a citizen petition requesting that the FDA declare Dapsone Tablets 50 mg suitable for submission in an abbreviated new drug application, with the reference listed drug being Dapsone Tablets USP 100 mg held by Everest Life Sciences LLC under ANDA 86842. The | Suitability | 2024-11-18 | Granted | Macleods Pharmaceuticals Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.9782
per ea
Lowest NADAC/Unit
$0.9782
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69367037901DAPSONE 100 MG TABLET | $0.9782 | EA | Generic | — | 2026-06-17 |
| 69367037930DAPSONE 100 MG TABLET | $0.9782 | EA | Generic | — | 2026-06-17 |
| 69367041001DAPSONE 100 MG TABLET | $0.9782 | EA | Generic | — | 2026-06-17 |
| 69367041030DAPSONE 100 MG TABLET | $0.9782 | 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.