Application 220103
- Type
- ANDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPSONE | DAPSONE | TABLET;ORAL | 25MG | No | No |
| 002 | DAPSONE | DAPSONE | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A220103-001 | DAPSONE | DAPSONE | 25MG | TABLET / ORAL | AB | 2026-02-26 | |
| A220103-002 | DAPSONE | DAPSONE | 100MG | TABLET / ORAL | AB | 2026-02-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A220103-001 | AB |
| A220103-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220103-001 | DAPSONE | 25MG | TABLET / ORAL | AB | 2026-02-26 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220103-002 | DAPSONE | 100MG | TABLET / ORAL | AB | 2026-02-26 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220103-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220103-002 | AB | 1 | a50c72e98297… |
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 | Viona Pharmaceuticals Inc | 58e7b363-99fb-4225-8df1-db2114d74928 | 2026-02-27 | Warnings, Adverse reactions | 220103 ANDA220103 |
| Dapsone | DAPSONE | Zydus Lifesciences Limited | 1d6bc112-ba2f-40ab-975d-9cfbc853cd11 | 2026-02-27 | 220103 ANDA220103 |