ORFADIN - nitisinone
Navigation: NDC > Supplier starting with: R > RARE DISEASE THERAPEUTICS, INC.| Field | Value |
|---|---|
| NDC Code: | 66621-1005 |
| Proprietary Name: | ORFADIN |
| Suffix: | |
| Non-Proprietary Name: | nitisinone |
| Dosage Form: | CAPSULE |
| Method: | ORAL |
| Original Marketing Date: | 18-01-2002 |
| Category Name: | NDA |
| Application Number: | NDA021232 |
| Labeler: | RARE DISEASE THERAPEUTICS, INC. |
| Substance Name: | NITISINONE |
| Active Numerator Strength: | 5 |
| Active Ingredient Unit: | mg/1 |
| Pharm Classes: | Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA] |
| DEA Schedule: |