Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214382
Company: SHANDONG
Company: SHANDONG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEVOFLURANE | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | AN | 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 |
|---|---|---|---|---|---|---|---|
| 08/18/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SEVOFLURANE
LIQUID;INHALATION; 100%
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SEVOFLURANE | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | No | AN | 075895 | BAXTER HLTHCARE |
| SEVOFLURANE | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | No | AN | 078650 | HALOCARBON PRODS |
| SEVOFLURANE | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | No | AN | 214382 | SHANDONG |
| SEVOFLURANE | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | No | AN | 203793 | SHANGHAI HENGRUI |
| SOJOURN | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | No | AN | 077867 | PIRAMAL CRITICAL |
| ULTANE | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | Yes | AN | 020478 | ABBVIE |