Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077867
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-Container/Carton Labels, Labeling-Package Insert

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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