Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075895
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| 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 |
|---|---|---|---|---|---|---|---|
| 07/02/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075895.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/02/2025 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2024 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/15/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/25/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/14/2005 | SUPPL-4 | Labeling |
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 |