Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075895
Company: BAXTER HLTHCARE

Products on ANDA 075895

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEVOFLURANE	SEVOFLURANE	100%	LIQUID;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075895

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
03/20/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 075895

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	214382	SHANDONG
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