Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208234
Company: SHANGHAI HENGRUI
Company: SHANGHAI HENGRUI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESFLURANE | DESFLURANE | 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 |
---|---|---|---|---|---|---|---|
02/26/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208234Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/30/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
DESFLURANE
LIQUID;INHALATION; 100%
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESFLURANE | DESFLURANE | 100% | LIQUID;INHALATION | Prescription | No | AN | 208234 | SHANGHAI HENGRUI |
SUPRANE | DESFLURANE | 100% | LIQUID;INHALATION | Prescription | Yes | AN | 020118 | BAXTER HLTHCARE |