| Product NDC: | 0378-9040 |
| Proprietary Name: | Cystagon |
| Non Proprietary Name: | cysteamine bitartrate |
| Active Ingredient(s): | 50 mg/1 & nbsp; cysteamine bitartrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0378-9040 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020392 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19940815 |
| Package NDC: | 0378-9040-05 |
| Package Description: | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-05) |
| NDC Code | 0378-9040-05 |
| Proprietary Name | Cystagon |
| Package Description | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-05) |
| Product NDC | 0378-9040 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | cysteamine bitartrate |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 19940815 |
| Marketing Category Name | NDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | CYSTEAMINE BITARTRATE |
| Strength Number | 50 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cysteine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] |