DAPSONE | A086841 | 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 |
Lachman Consultant Sevices, Inc.- Citizen Petition FDA-2013-P-0800 Lachman Consultant Services, Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Dapsone Tablets, 50 mg, suitable for submission as an ANDA, with the reference listed drug being Dapsone Tablets USP, 100 mg (ANDA | Other | 2013-07-15 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4539
per ea
Lowest NADAC/Unit
$0.4539
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69367037801DAPSONE 25 MG TABLET | $0.4539 | EA | Generic | — | 2026-10-21 |
| 69367037830DAPSONE 25 MG TABLET | $0.4539 | EA | Generic | — | 2026-10-21 |
| 69367040901DAPSONE 25 MG TABLET | $0.4539 | EA | Generic | — | 2026-10-21 |
| 69367040930DAPSONE 25 MG TABLET | $0.4539 | 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.