FDA.reportPublic FDA data

CYCLOSPORINE - Food and Drug Administration

Set ID
1be408a0-e15a-4092-b35e-4e294e65196f
Type
Indexing - product concept
Effective date
2024-02-16
Version
3
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) Rx only Prescribing InformationProduct nameApotex Corp.2026-09-10
CYCLOSPORINE, MODIFIED - cyclosporine capsule, liquid filled Strides Pharma, Inc. Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) Rx only Prescribing InformationProduct nameStrides Pharma Science Limited | Onesource Softgels Pte. Ltd.2026-08-27
Cyclosporine AProduct nameAX Pharmaceutical Corp2026-08-25
NEORAL ® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED NEORAL ® Oral Solution (cyclosporine oral solution, USP) MODIFIED Rx only Prescribing InformationProduct nameNovartis Pharmaceuticals Corporation2026-08-10
Atopica™ for Cats (cyclosporine oral solution) USP MODIFIED 100 mg/mLProduct nameElanco US Inc.2026-07-22
NEORAL ® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED NEORAL ® Oral Solution (cyclosporine oral solution, USP) MODIFIED Rx only Prescribing InformationProduct nameNovartis Pharmaceuticals Corporation2026-07-10
Sandimmune ® (cyclosporine capsules), for oral use Sandimmune ® (cyclosporine injection), for intravenous use Prescribing InformationProduct nameNovartis Pharmaceuticals Corporation2026-07-10
These highlights do not include all the information needed to use CEQUA safely and effectively. See full prescribing information for CEQUA. CEQUA ® (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameSun Pharmaceutical Industries, Inc. | Laboratoire Unither | TAPI Czech Industries s.r.o.2026-06-15
Cyclosporine AProduct nameAX Pharmaceutical Corp2026-06-08
These highlights do not include all the information needed to use VERKAZIA safely and effectively. See full prescribing information for VERKAZIA. Verkazia® (cyclosporine ophthalmic emulsion) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameHarrow Eye, LLC | Excelvision2026-06-03
These highlights do not include all the information needed to use CYCLOSPORINE OPHTHALMIC EMULSION safely and effectively.see full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSIONCYCLOSPORINE ophthalmic emulsion Initial U.S. Approval: 1983Product nameUpsher-Smith Laboratories, LLC | TWi Pharmaceuticals, Inc. | Qilu Pharmaceutical Co., Ltd.2026-05-22
Cyclosporine AProduct nameAX Pharmaceutical Corp2026-05-08
CYCLOSPORINE CAPSULES, USP 25 mg and 100 mg Rx only Prescribing InformationProduct nameApotex Corp. | Apotex Inc.2026-04-22
These highlights do not include all the information needed to use VERKAZIA safely and effectively. See full prescribing information for VERKAZIA. Verkazia® (cyclosporine ophthalmic emulsion) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameHarrow Eye, LLC | Excelvision2026-03-24
Sandimmune ® (cyclosporine capsules), for oral use Sandimmune ® (cyclosporine injection), for intravenous use Prescribing InformationProduct nameNovartis Pharmaceuticals Corporation2026-03-06
These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameHarrow Eye, LLC2026-02-26
Atopica™Product nameElanco US Inc.2026-02-20
Cyclosporine Capsules, USP [Modified](Soft Gelatin) Cyclosporine ORAL SOLUTION, USP [Modified]Product nameMayne Pharma Inc. | Patheon Softgels Inc. | Carton Service Incorporated | Sharp Corporation2026-02-12
These highlights do not include all the information needed to use CYCLOSPORINE OPHTHALMIC EMULSION safely and effectively.see full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSIONCYCLOSPORINE ophthalmic emulsion Initial U.S. Approval: 1983Product nameUpsher-Smith Laboratories, LLC | TWi Pharmaceuticals, Inc. | Qilu Pharmaceutical Co., Ltd.2026-01-22
Optimmune ® (0.2% Cyclosporine, USP) Ophthalmic OintmentProduct nameMerck Sharp & Dohme Corp.2026-01-16
Atopica™ for Cats (cyclosporine oral solution) USP MODIFIED 100 mg/mLProduct nameElanco US Inc.2026-01-15
These highlights do not include all the information needed to use VERKAZIA safely and effectively. See full prescribing information for VERKAZIA. Verkazia® (cyclosporine ophthalmic emulsion) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameHarrow Eye, LLC2026-01-15
NEORAL ® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED NEORAL ® Oral Solution (cyclosporine oral solution, USP) MODIFIED Rx only Prescribing InformationProduct nameNovartis Pharmaceuticals Corporation2025-12-22
Sandimmune ® Soft Gelatin Capsules (cyclosporine capsules, USP) Sandimmune ® Oral Solution (cyclosporine oral solution, USP) Sandimmune ® Injection (cyclosporine injection, USP) FOR INFUSION ONLY Rx only Prescribing InformationProduct nameNovartis Pharmaceuticals Corporation2025-12-22
Optimmune ® (0.2% Cyclosporine, USP) Ophthalmic OintmentProduct nameMerck Sharp & Dohme Corp.2025-12-19
These highlights do not include all the information needed to use CYCLOSPORINE OPHTHALMIC EMULSION safely and effectively. See full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSION . CYCLOSPORINE ophthalmic emulsion Initial U.S. Approval: 1983Product nameSaptalis Pharmaceuticals, LLC | Taejoon Pharmaceutical Co., Ltd.2025-12-09
CYCLOSPORINE, MODIFIED - cyclosporine capsule, liquid filled Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) Rx only Prescribing InformationProduct nameHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2025-12-04
These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameHarrow Eye, LLC2025-11-14
Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) Rx only Prescribing InformationProduct nameApotex Corp.2025-09-17
These highlights do not include all the information needed to use RESTASIS MULTIDOSE safely and effectively. See full prescribing information for RESTASIS MULTIDOSE . RESTASIS MULTIDOSE ® ( cyclosporine ophthalmic emulsion ) 0.05% , f or topical ophthalmic use Initial U.S. Approval: 1983Product nameAllergan, Inc.2025-08-21
These highlights do not include all the information needed to use CEQUA safely and effectively. See full prescribing information for CEQUA. CEQUA ® (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameSun Pharmaceutical Industries, Inc. | Laboratoire Unither | Teva Czech Industries s.r.o2025-03-06
These highlights do not include all the information needed to use CYCLOSPORINE OPHTHALMIC EMULSION safely and effectively. See full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSION. CYCLOSPORINE ophthalmic emulsion, for topical ophthalmic use Initial U.S. Approval: 1983Product nameAmneal Pharmaceuticals NY LLC | Unither Manufacturing LLC2025-02-27
These highlights do not include all the information needed to use CYCLOSPORINE ophthalmic emulsion safely and effectively. See full prescribing information for CYCLOSPORINE ophthalmic emulsion. CYCLOSPORINE ophthalmic emulsion, For topical ophthalmic use Initial U.S. Approval: 1983Product nameDevatis Inc. | Deva Holding A.S.2025-02-17
These highlights do not include all the information needed to use CYCLOSPORINE OPHTHALMIC EMULSION safely and effectively. See full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSION. CYCLOSPORINE ophthalmic emulsion, for topical ophthalmic use Initial U.S. Approval: 1983Product nameAmneal Pharmaceuticals NY LLC | Unither Manufacturing LLC2025-02-12
These highlights do not include all the information needed to use VERKAZIA safely and effectively. See full prescribing information for VERKAZIA. Verkazia® (cyclosporine ophthalmic emulsion) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameSanten Incorporated2025-01-17
These highlights do not include all the information needed to use CYCLOSPORINE OP H THALMIC EMULSION, 0.05% safely and effectively. See full prescribing information for cyclosporine ophthalmic emulsion, 0.05% . CYCLOSPORINE OP H THALMIC EMULSION, 0.05% For topical ophthalmic use Initial U.S. Approval: 1983Product nameKVK-TECH, INC.2024-09-23
These highlights do not include all the information needed to use CYCLOSPORINE OP H THALMIC EMULSION, 0.05% safely and effectively. See full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSION, 0.05%. CYCLOSPORINE OP H THALMIC EMULSION, 0.05% For topical ophthalmic use Initial U.S. Approval: 1983Product nameApotex Corp2024-09-23
These highlights do not include all the information needed to use RESTASIS 0.05% safely and effectively. See full prescribing information for RESTASIS . RESTASIS ® ( cyclosporine ophthalmic emulsion ) 0.05% For topical ophthalmic use Initial U.S. Approval: 1983Product nameAllergan, Inc.2024-09-09
These highlights do not include all the information needed to use CYCLOSPORINE OPHTHALMIC EMULSION, 0.05% safely and effectively. See full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSION, 0.05%. CYCLOSPORINE OPHTHALMIC EMULSION, 0.05% For topical ophthalmic use Initial U.S. Approval: 1983Product nameLupin Pharmaceuticals, Inc.2024-09-01
GENGRAF ® Capsules (cyclosporine capsules, USP [MODIFIED])Product nameAbbVie Inc.2024-08-21
Modulis ® for Cats (cydosporine oral solution) USP ModifiedProduct nameCeva Sante Animale2024-08-05
Modulis ® for Dogs (cyclosporine oral solution) USP MODIFIED 100 mg/mLProduct nameCeva Sante Animale2024-08-05
cycloSPORINE Oral Solution, USP MODIFIEDProduct nameTeva Pharmaceuticals USA, Inc.2024-07-01
Cyclosporine Capsules, USP [Modified](Soft Gelatin) Cyclosporine ORAL SOLUTION, USP [Modified]Product nameDr. Reddy's Laboratories Inc2024-06-03
These highlights do not include all the information needed to use RESTASIS ® 0.05% safely and effectively. See full prescribing information for RESTASIS ® . RESTASIS ® ( cyclosporine ophthalmic emulsion ) 0.05% For topical ophthalmic use Initial U.S. Approval: 1983Product nameA-S Medication Solutions2024-05-24
Cyclosporine Capsules, USP Rx Only 8287925/0424F Prescribing InformationProduct nameAmerican Health Packaging2024-05-13
CYCLAVANCE® (cyclosporine oral solution) USP MODIFIEDProduct nameVirbac AH Inc2024-04-29
cycloSPORINE Capsules, USP MODIFIED (Soft Gelatin Capsules)Product nameTeva Pharmaceuticals USA, Inc.2024-04-01
These highlights do not include all the information needed to use CYCLOSPORINE OPHTHALMIC EMULSION 0.05% safely and effectively. See full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSION. CYCLOSPORINE ophthalmic emulsion, 0.05% For topical ophthalmic use Initial U.S. Approval: 1983Product nameTeva Pharmaceuticals, Inc.2024-03-01
CYCLOSPORINE, MODIFIED - cyclosporine capsule, liquid filled Rx only Prescribing InformationProduct nameStrides Pharma Science Limited2024-02-22
These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983Product nameHarrow Eye, LLC2023-11-21
Sporimune™ (cyclosporine capsules) USP MODIFIEDProduct nameDechra Veterinary Products LLC2023-09-29
These highlights do not include all the information needed to use CYCLOSPORINE OPHTHALMIC EMULSION 0.05% safely and effectively. See full prescribing information for CYCLOSPORINE OPHTHALMIC EMULSION . CYCLOSPORINE ophthalmic emulsion 0.05% For topical ophthalmic use Initial U.S. Approval: 1983Product nameMylan Pharmaceuticals Inc.2022-01-20
These highlights do not include all the information needed to use RESTASIS ® 0.05% safely and effectively. See full prescribing information for RESTASIS ® . RESTASIS ® ( cyclosporine ophthalmic emulsion ) 0.05% For topical ophthalmic use Initial U.S. Approval: 1983Product nameA-S Medication Solutions2021-04-14
Imprimis NJOF, LLC human prescription drug labelProduct nameImprimis NJOF, LLC2020-02-10
ImprimisRx NJ human prescription drug labelProduct nameImprimisRx NJ2018-02-26
AX Pharmaceutical Corp bulk ingredientProduct nameAX Pharmaceutical Corp2016-12-14
Cyclosporin AProduct nameAMERICAN PHARMACEUTICAL INGREDIENTS LLC2013-10-31
CYCLOSPORINE CAPSULES, USP 25 mg and 100 mgProduct namePhysicians Total Care, Inc.2011-06-21
CYCLOSPORINE CAPSULES USP MODIFIED (Soft Gelatin Capsules) Rx onlyProduct namePhysicians Total Care, Inc.2010-08-31
RESTASIS ® (cyclosporine ophthalmic emulsion) 0.05%Product namePhysicians Total Care, Inc.2010-05-27