Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220736
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIFFERIN EPIDUO | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Over-the-counter | None | Yes | Yes |
| DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | 15G | GEL | Over-the-counter | None | No | No |
| DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | 30G | GEL | Over-the-counter | None | No | No |
| DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | 45G | GEL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/22/2026 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220736Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220736Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/22/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220736Orig1s000lbl.pdf |
DIFFERIN EPIDUO
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
GEL;TOPICAL; 0.1%;2.5%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| DIFFERIN EPIDUO | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Over-the-counter | Yes | 220736 | GALDERMA LABS LP |
DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
GEL; 45G
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | 45G | GEL | Over-the-counter | No | 220736 | GALDERMA LABS LP |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
GEL; 30G
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | 30G | GEL | Over-the-counter | No | 220736 | GALDERMA LABS LP |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
GEL; 15G
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | ADAPALENE, BENZOYL PEROXIDE | 15G | GEL | Over-the-counter | No | 220736 | GALDERMA LABS LP |