ORFADIN (Swedish Orphan Biovitrum AB (publ))
Welcome to the PulseAid listing for the ORFADIN drug offered from Swedish Orphan Biovitrum AB (publ). This 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] pharmaceutical is classified as a HUMAN PRESCRIPTION DRUG. Below, you can view details for this drug, such as its dosage form, route of delivery, start market/end market dates, and more. We have also randomly listed additional pharmaceuticals used in the same HUMAN PRESCRIPTION DRUG drug type category.
| LABELER NAME / MANUFACTURER: | Swedish Orphan Biovitrum AB (publ) |
| NON-PROPRIETARY NAME: | nitisinone |
| SUBSTANCE NAME: | NITISINONE |
| TYPE: | HUMAN PRESCRIPTION DRUG |
| PHARMA CLASS: | 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] |
| ROUTE: | ORAL |
| DOSAGE FORM: | SUSPENSION |
| MARKETING CATEGORY NAME: | NDA |
| START MARKETING DATE: | 2016-06-01 |
| END MARKETING DATE: | 0000-00-00 |
ORFADIN HUMAN PRESCRIPTION DRUG Details:
| Item Description | ORFADIN from Swedish Orphan Biovitrum AB (publ) |
| LABELER NAME: | Swedish Orphan Biovitrum AB (publ) |
| DEA SCHEDULE: |
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| ACTIVE STRENGTH: | 4(mg/mL) |
| START MARKETING DATE: | 2016-06-01 |
| END MARKETING DATE: | 0000-00-00 |
| PRODUCT ID: | 66658-204_aebb1cd4-3770-4843-adaa-d503797060d3 |
| PRODUCT NDC: | 66658-204 |
| APPLICATION NUMBER: | NDA206356 |
Other NITISINONE Pharmaceutical Manufacturers / Labelers:
