Product NDC: | 54482-020 |
Proprietary Name: | CYSTARAN |
Non Proprietary Name: | cysteamine hydrochloride |
Active Ingredient(s): | 6.5 mg/mL & nbsp; cysteamine hydrochloride |
Administration Route(s): | OPHTHALMIC |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54482-020 |
Labeler Name: | Sigma-Tau Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA200740 |
Marketing Category: | NDA |
Start Marketing Date: | 20121230 |
Package NDC: | 54482-020-01 |
Package Description: | 15 mL in 1 BOTTLE (54482-020-01) |
NDC Code | 54482-020-01 |
Proprietary Name | CYSTARAN |
Package Description | 15 mL in 1 BOTTLE (54482-020-01) |
Product NDC | 54482-020 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | cysteamine hydrochloride |
Dosage Form Name | SOLUTION |
Route Name | OPHTHALMIC |
Start Marketing Date | 20121230 |
Marketing Category Name | NDA |
Labeler Name | Sigma-Tau Pharmaceuticals, Inc. |
Substance Name | CYSTEAMINE HYDROCHLORIDE |
Strength Number | 6.5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Cysteine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] |