Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022172
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEROQUEL XR | QUETIAPINE FUMARATE | 50MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | None | No | No |
| SEROQUEL XR | QUETIAPINE FUMARATE | 200MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | None | No | No |
| SEROQUEL XR | QUETIAPINE FUMARATE | 300MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | None | No | No |
| SEROQUEL XR | QUETIAPINE FUMARATE | 400MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 11/15/2007 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022172s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022172s000_seroquel_xr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022172s000_SumR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/15/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022172lbl.pdf |