Regulatory Exclusivity: PEDIATRIC EXCLUSIVITY
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Drugs with Pediatric Exclusivity Regulatory Exclusivity
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-002 | Nov 22, 2022 | RX | Yes | No | ⤷ Subscribe | PEDIATRIC EXCLUSIVITY | |
| Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-001 | Mar 6, 2015 | RX | Yes | Yes | ⤷ Subscribe | PEDIATRIC EXCLUSIVITY | |
| Astellas | CRESEMBA | isavuconazonium sulfate | POWDER;INTRAVENOUS | 207501-001 | Mar 6, 2015 | RX | Yes | Yes | ⤷ Subscribe | PEDIATRIC EXCLUSIVITY | |
| Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-002 | Nov 22, 2022 | RX | Yes | No | ⤷ Subscribe | PEDIATRIC EXCLUSIVITY | |
| Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-001 | Mar 6, 2015 | RX | Yes | Yes | ⤷ Subscribe | PEDIATRIC EXCLUSIVITY | |
| Astellas | CRESEMBA | isavuconazonium sulfate | POWDER;INTRAVENOUS | 207501-001 | Mar 6, 2015 | RX | Yes | Yes | ⤷ Subscribe | PEDIATRIC EXCLUSIVITY | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
