Product NDC: | 54868-4793 |
Proprietary Name: | RESTASIS |
Non Proprietary Name: | cyclosporine |
Active Ingredient(s): | .5 mg/mL & nbsp; cyclosporine |
Administration Route(s): | OPHTHALMIC |
Dosage Form(s): | EMULSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-4793 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA050790 |
Marketing Category: | NDA |
Start Marketing Date: | 20090327 |
Package NDC: | 54868-4793-1 |
Package Description: | 30 VIAL, SINGLE-DOSE in 1 TRAY (54868-4793-1) > .4 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 54868-4793-1 |
Proprietary Name | RESTASIS |
Package Description | 30 VIAL, SINGLE-DOSE in 1 TRAY (54868-4793-1) > .4 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 54868-4793 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | cyclosporine |
Dosage Form Name | EMULSION |
Route Name | OPHTHALMIC |
Start Marketing Date | 20090327 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | CYCLOSPORINE |
Strength Number | .5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] |