PROCYSBI - Cysteamine Bitartrate
Navigation: NDC > Supplier starting with: R > RAPTOR THERAPEUTICS INC.| Field | Value |
|---|---|
| NDC Code: | 49663-001 |
| Proprietary Name: | PROCYSBI |
| Suffix: | Delayed-release |
| Non-Proprietary Name: | Cysteamine Bitartrate |
| Dosage Form: | CAPSULE, DELAYED RELEASE PELLETS |
| Method: | ORAL |
| Original Marketing Date: | 30-04-2013 |
| Category Name: | NDA |
| Application Number: | NDA203389 |
| Labeler: | RAPTOR THERAPEUTICS INC. |
| Substance Name: | CYSTEAMINE BITARTRATE |
| Active Numerator Strength: | 25 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | Cysteine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] |
| DEA Schedule: |