Application 220736
- Type
- NDA
- Sponsor
- GALDERMA LABORATORIES, L.P
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | GEL | 2G | No | No |
| 002 | DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | GEL | 15G | No | No |
| 003 | DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | GEL | 30G | No | No |
| 004 | DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | GEL | 45G | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N220736-001 | DIFFERIN EPIDUO | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL / TOPICAL | RLD, RS | 2026-05-22 |
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 | N220736-001 | DIFFERIN EPIDUO | 0.1%;2.5% | GEL / TOPICAL | RLD, RS | 2026-05-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N220736-001 | DIFFERIN EPIDUO | 0.1%;2.5% | GEL / TOPICAL | RLD, RS | 2026-05-22 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N220736-001 | DIFFERIN EPIDUO | 0.1%;2.5% | GEL / TOPICAL | RLD, RS | 2026-05-22 | 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 |
|---|---|---|---|---|---|---|
| Differin Epiduo | ADAPALENE AND BENZOYL PEROXIDE | Galderma Laboratories, L.P. | ae3f8cd9-9046-4b69-b80f-3e9d4468ba7f | 2026-05-20 | Warnings | 220736 NDA220736 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.