Active ingredient
Calcipotriene
11 finished FDA listings contain Calcipotriene as their only active ingredient; 11 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CALCIPOTRIENE, CALCIPOTRIENE HYDRATE, CALCIPOTRIENE MONOHYDRATE
- Dosage forms
- Aerosol, Foam, Cream, Ointment, Solution
- Routes
- Topical
- Manufacturers / labelers
- 8
- Strengths listed
- .05 mg/g · .05 mg/ml · 50 ug/g
- Brand names in FDA listings
- Calcitrene, Pellix, Sorilux
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 29365
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 |
|---|---|---|---|
| NDA 020273 | LEO PHARMA AS | 1993-12-29 | 1 |
| NDA 020554 | LEO PHARMA AS | 1996-07-22 | 1 |
| ANDA 090633 | GLENMARK PHARMS | 2010-03-24 | 3 |
| NDA 022563 | MAYNE PHARMA | 2010-10-06 | 2 |
| ANDA 078468 | COSETTE PHARMS NC | 2011-03-24 | 2 |
| ANDA 205772 | GLENMARK SPECLT | 2015-06-09 | 2 |
Official labeling on DailyMed
- CALCIPOTRIENE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 5 · 2026-07-15
- CALCITRENE (CALCIPOTRIENE) OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 4 · 2026-07-15
- PELLIX (CALCIPOTRIENE) SOLUTION [PERFERO PHARMA, INC.] · version 2 · 2026-05-06
- CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] · version 9 · 2026-01-26
- CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] · version 7 · 2025-11-17
- CALCIPOTRIENE CREAM [NORTHSTAR RX LLC] · version 4 · 2024-06-25
- CALCIPOTRIENE AEROSOL, FOAM [MAYNE PHARMA] · version 4 · 2024-05-13
- SORILUX (CALCIPOTRIENE) AEROSOL, FOAM [MAYNE PHARMA] · version 7 · 2024-05-13
- CALCIPOTRIENE CREAM [PRASCO LABORATORIES] · version 10 · 2022-12-13
- CALCIPOTRIENE SOLUTION [COSETTE PHARMACEUTICALS, INC.] · version 10 · 2022-11-16
- CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES] · version 9 · 2020-08-13
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.