| 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] |