DAPSONE | A086842 | EVEREST LIFE SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Macleods Pharmaceuticals Limited FDA-2024-P-5379 Macleods Pharmaceuticals Limited filed an amendment to suitability petition FDA-2024-P-5379 on December 12, 2024, seeking FDA declaration that Dapsone Tablets, 50 mg, is suitable for submission as an ANDA, with the reference listed drug being Dapsone Tablets USP, 100 mg (ANDA 86842). The company pro | Suitability | 2024-12-12 | Granted | Macleods Pharmaceuticals Limited |
Suitability Petition from Macleods Pharmaceuticals Limited FDA-2024-P-5379 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
$0.7994
per ea
Lowest NADAC/Unit
$0.7994
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69367037901DAPSONE 100 MG TABLET | $0.7994 | EA | Generic | — | 2026-10-21 |
| 69367037930DAPSONE 100 MG TABLET | $0.7994 | EA | Generic | — | 2026-10-21 |
| 69367041001DAPSONE 100 MG TABLET | $0.7994 | EA | Generic | — | 2026-10-21 |
| 69367041030DAPSONE 100 MG TABLET | $0.7994 | 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.