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PROCYSBI
PROCYSBI - 49663-001-06 - (Cysteamine Bitartrate)
Drug Information of PROCYSBI
| Product NDC: | 49663-001 |
| Proprietary Name: | PROCYSBI |
| Non Proprietary Name: | Cysteamine Bitartrate |
| Active Ingredient(s): | 25 mg/1 & nbsp; Cysteamine Bitartrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, DELAYED RELEASE PELLETS |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of PROCYSBI
| Product NDC: | 49663-001 |
| Labeler Name: | RAPTOR THERAPEUTICS INC. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203389 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130430 |
Package Information of PROCYSBI
| Package NDC: | 49663-001-06 |
| Package Description: | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (49663-001-06) |
NDC Information of PROCYSBI
| NDC Code | 49663-001-06 |
| Proprietary Name | PROCYSBI |
| Package Description | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (49663-001-06) |
| Product NDC | 49663-001 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Cysteamine Bitartrate |
| Dosage Form Name | CAPSULE, DELAYED RELEASE PELLETS |
| Route Name | ORAL |
| Start Marketing Date | 20130430 |
| Marketing Category Name | NDA |
| Labeler Name | RAPTOR THERAPEUTICS INC. |
| Substance Name | CYSTEAMINE BITARTRATE |
| Strength Number | 25 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cysteine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] |
