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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216527
Company: SHANDONG

Products on ANDA 216527

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216527

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216527

ISOFLURANE

LIQUID;INHALATION; 99.9%
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FORANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	Yes	AN	017624	BAXTER HLTHCARE
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	No	AN	075225	HALOCARBON PRODS
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	No	AN	074416	PIRAMAL CRITICAL
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	No	AN	074502	PIRAMAL PHARMA
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	No	AN	216527	SHANDONG

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