Active ingredient
Acitretin
24 finished FDA listings contain Acitretin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ACITRETIN
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 10 mg/1 · 17.5 mg/1 · 22.5 mg/1 · 25 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 16818
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 091455 | BARR LABS INC | 2013-04-04 | 2 |
| ANDA 202897 | TEVA PHARMS USA | 2013-04-04 | 1 |
| ANDA 204633 | SIGMAPHARM LABS LLC | 2015-05-22 | 9 |
| ANDA 202148 | MYLAN | 2015-09-10 | 2 |
| ANDA 202552 | IMPAX LABS INC | 2015-12-23 | 4 |
| ANDA 217774 | ALEMBIC | 2024-08-05 | 6 |
Official labeling on DailyMed
- ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC] · version 8 · 2026-08-07
- ACITRETIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · version 15 · 2025-09-29
- ACITRETIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 18 · 2025-07-17
- ACITRETIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2024-08-12
- ACITRETIN CAPSULE [ALEMBIC PHARMACEUTICALS INC.] · version 5 · 2024-08-12
- ACITRETIN CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2024-01-29
- ACITRETIN CAPSULE [BRYANT RANCH PREPACK] · version 100 · 2024-01-29
- ACITRETIN CAPSULE [BRYANT RANCH PREPACK] · version 100 · 2024-01-29
- ACITRETIN CAPSULE [AVKARE] · version 7 · 2024-01-24
- ACITRETIN CAPSULE [MYLAN PHARMACEUTICALS INC.] · version 16 · 2024-01-22
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.