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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208234
Company: SHANGHAI HENGRUI

Products on ANDA 208234

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208234

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.

Therapeutic Equivalents for ANDA 208234

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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