Active ingredient
Cyclosporine
47 finished FDA listings contain Cyclosporine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CYCLOSPORINE
- Dosage forms
- Capsule, Capsule, Gelatin Coated, Capsule, Liquid Filled, Emulsion, Injection, Solution, Solution/ Drops
- Routes
- Intravenous, Ophthalmic, Oral, Topical
- Manufacturers / labelers
- 23
- Strengths listed
- .0009 g/ml · .0009 mg/ml · .5 mg/ml · 1 mg/ml · 100 mg/1 · 100 mg/ml · 25 mg/1 · 50 mg/1 · 50 mg/ml
- Brand names in FDA listings
- Cequa, Cyclosporine Modified, Cyclosporine, Modfied, Gengraf, Neoral, Restasis, Restasis Multidose, Sandimmune, Verkazia, Vevye
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3008
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 050573 | NOVARTIS | 1983-11-14 | 1 |
| NDA 050625 | NOVARTIS | 1990-03-02 | 2 |
| NDA 050716 | NOVARTIS | 1995-07-14 | 1 |
| NDA 050715 | NOVARTIS | 1995-07-14 | 2 |
| ANDA 065003 | ABBVIE | 2000-05-12 | 2 |
| ANDA 065044 | DR REDDYS LABS SA | 2000-12-20 | 2 |
| ANDA 065040 | APOTEX | 2002-05-09 | 4 |
| NDA 050790 | ABBVIE | 2002-12-23 | 6 |
| ANDA 065078 | IVAX SUB TEVA PHARMS | 2005-03-25 | 1 |
| ANDA 065110 | IVAX SUB TEVA PHARMS | 2005-03-29 | 3 |
| NDA 210913 | SUN PHARM | 2018-08-14 | 2 |
| ANDA 210721 | APOTEX | 2019-07-10 | 3 |
| NDA 214965 | HARROW EYE | 2021-06-23 | 2 |
| ANDA 205894 | MYLAN | 2022-02-02 | 1 |
| ANDA 216046 | ONESOURCE | 2022-08-02 | 6 |
| NDA 217469 | HARROW EYE | 2023-05-30 | 1 |
| ANDA 203880 | TEVA PHARMS USA INC | 2023-12-14 | 1 |
| ANDA 209811 | DEVA HOLDING AS | 2024-05-21 | 1 |
| ANDA 211943 | SAPTALIS PHARMS | 2024-07-05 | 1 |
| ANDA 209064 | TWI PHARMS | 2026-01-21 | 1 |
| ANDA 219288 | JIANGSU ANBISON | 2026-06-01 | 1 |
| ANDA 219652 | AUROBINDO PHARMA LTD | 2026-09-17 | 3 |
Official labeling on DailyMed
- CYCLOSPORINE, MODFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [APOTEX CORP.] · version 10 · 2026-09-11
- CYCLOSPORINE (CYCLOSPORINE) CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED] · version 7 · 2026-08-31
- NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] · version 30 · 2026-08-11
- SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] · version 37 · 2026-07-13
- CEQUA (CYCLOSPORINE) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 13 · 2026-06-26
- VERKAZIA (CYCLOSPORINE) EMULSION [HARROW EYE, LLC] · version 5 · 2026-06-05
- CYCLOSPORINE EMULSION [UPSHER-SMITH LABORATORIES, LLC] · version 2 · 2026-05-25
- GENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.] · version 1256 · 2026-05-21
- CYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.] · version 15 · 2026-04-29
- VEVYE (CYCLOSPORINE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [HARROW EYE, LLC] · version 4 · 2026-03-02
- CYCLOSPORINE EMULSION [SAPTALIS PHARMACEUTICALS, LLC] · version 1 · 2025-12-12
- CYCLOSPORINE CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 5 · 2025-12-05
Showing the 12 most recent of 26 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.