Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075895
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
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 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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