Application 212657
- Type
- ANDA
- Sponsor
- PADAGIS ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPSONE | DAPSONE | GEL;TOPICAL | 7.5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212657-001 | DAPSONE | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | AB | 2023-11-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | AB | 2023-11-01 | a72a2bbeb626… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212657-001 | DAPSONE | 7.5% | GEL / TOPICAL | 2023-11-01 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-12-20 04:57 UTC | 2023-12 | A212657-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212657-001 | AB | 1 | a72a2bbeb626… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dapsone | DAPSONE | Mayne Pharma Commercial LLC | cbf9e81e-00ef-4218-975e-6a1610b7f1dd | 2025-06-09 | Warnings, Adverse reactions | Dapsone DAPSONE |
| dapsone | DAPSONE | Torrent Pharmaceuticals Limited | f8cffc24-8310-4f21-ae77-7f6ad6095551 | 2025-06-05 | Warnings, Adverse reactions | dapsone DAPSONE |
| DAPSONE | DAPSONE | Aurobindo Pharma Limited | acd33f0b-8563-467a-93db-a11902331528 | 2025-05-30 | Warnings, Adverse reactions | DAPSONE DAPSONE |
| Dapsone | DAPSONE | Chartwell RX, LLC | 93028aff-54f0-4f94-b925-a91400118294 | 2025-04-29 | Warnings, Adverse reactions | Dapsone DAPSONE |
| Dapsone | DAPSONE | Alembic Pharmaceuticals Inc. | 2811f7de-13bf-45cd-8413-5b04d11f40ff | 2025-04-03 | Warnings, Adverse reactions | Dapsone DAPSONE |
| DAPSONE | DAPSONE | ANI Pharmaceuticals, Inc. | 57a47368-d1f6-4d61-a2ee-c5f1fe7ff690 | 2025-02-11 | Warnings, Adverse reactions | DAPSONE DAPSONE |
| Dapsone | DAPSONE | Coupler LLC | 2d018cbb-21b2-5f63-e063-6394a90aadc3 | 2025-01-31 | Warnings, Adverse reactions | Dapsone DAPSONE |
| Dapsone | DAPSONE | Golden State Medical Supply, Inc. | 69248ad0-6998-42a2-88a9-fa682e5ea5ee | 2024-12-06 | Warnings, Adverse reactions | Dapsone DAPSONE |
| Dapsone | DAPSONE | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 20e8ca55-513e-8935-e063-6394a90a11cd | 2024-08-30 | Warnings, Adverse reactions | Dapsone DAPSONE |
| Dapsone | DAPSONE | Mylan Pharmaceuticals Inc. | e04da0a1-d02a-487d-a931-a31034738fdd | 2024-05-31 | Warnings, Adverse reactions | Dapsone DAPSONE |
| Dapsone | DAPSONE | Viona Pharmaceuticals Inc | 30867c69-cf3c-4360-8e56-db96e0b0c3ab | 2024-05-11 | Warnings, Adverse reactions | Dapsone DAPSONE |
| Dapsone | DAPSONE | Zydus Lifesciences Limited | 8b63b653-0507-4f95-9bfa-70fd071e15a6 | 2024-05-09 | Dapsone DAPSONE | |
| Dapsone | DAPSONE | Proficient Rx LP | 9cfe5fe7-abc7-4f48-a597-1b1a5c70a354 | 2024-05-01 | Warnings, Adverse reactions | Dapsone DAPSONE |
| Dapsone | DAPSONE | Mayne Pharma | dc495e54-8917-42de-a9fa-1f961bd99d61 | 2024-01-31 | Warnings, Adverse reactions | Dapsone DAPSONE |
| Dapsone | DASPONE | Amneal Pharmaceuticals NY LLC | fba0b181-077a-4667-bde1-cf9592f120c2 | 2023-05-31 | Warnings, Adverse reactions | Dapsone |
| DAPSONE | DAPSONE | Cosette Pharmaceuticals, Inc. | bc035edf-50d0-47ba-9b60-fe394ab3c32f | 2023-05-08 | Warnings, Adverse reactions | DAPSONE DAPSONE |
| Dapsone | DAPSONE | Amneal Pharmaceuticals LLC | f3e33970-ac11-4bb6-9f39-6f58d86fdefb | 2020-05-24 | Warnings, Adverse reactions | Dapsone DAPSONE |
| DAPSONE | DAPSONE | Pacific Pharma, Inc. | 8dbe1a41-6d9d-414f-aa9c-09bd95857e2a | 2018-09-30 | Warnings, Adverse reactions | DAPSONE DAPSONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.