Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208234
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

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