FDA Approval for TARPEYO issued to CALLIDITAS THERAPEUTICS AB
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215935
Company: CALLIDITAS THERAPEUTICS AB
Company: CALLIDITAS THERAPEUTICS AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TARPEYO | BUDESONIDE | 4MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | TBD | TBD | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/15/2021 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY; Orphan |
Label is not available on this site. |
TARPEYO
There are no Therapeutic Equivalents.