Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216579
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYMBICORT AEROSPHERE | BUDESONIDE; FORMOTEROL FUMARATE | 0.16MG/INH;0.0048MG/INH | AEROSOL, METERED;INHALATION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/28/2023 | ORIG-1 | Approval | Efficacy | STANDARD |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216579s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216579Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/28/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216579s000lbl.pdf |