Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 077867
Company: PIRAMAL CRITICAL
Company: PIRAMAL CRITICAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOJOURN | 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 |
|---|---|---|---|---|---|---|---|
| 05/02/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/16/2015 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/16/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/16/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2012 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/16/2011 | SUPPL-4 | Labeling |
Label is not available on this site. |
SOJOURN
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 | 203793 | SHANGHAI HENGRUI |
| SOJOURN | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | No | AN | 077867 | PIRAMAL CRITICAL |
| ULTANE | SEVOFLURANE | 100% | LIQUID;INHALATION | Prescription | Yes | AN | 020478 | ABBVIE |
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