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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216527

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NDA 216527 describes ISOFLURANE, which is a drug marketed by Halocarbon Prods, Hospira, Piramal Critical, Piramal Pharma, Shandong, and Watson Labs Inc, and is included in six NDAs. It is available from four suppliers. Additional details are available on the ISOFLURANE profile page.

The generic ingredient in ISOFLURANE is isoflurane. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isoflurane profile page.

Summary for 216527

Tradename:	ISOFLURANE
Applicant:	Shandong
Ingredient:	isoflurane
Patents:	0

Pharmacology for NDA: 216527

Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 216527

Anesthetics, Inhalation

Suppliers and Packaging for NDA: 216527

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOFLURANE	isoflurane	LIQUID;INHALATION	216527	ANDA	Shandong New Time Pharmaceutical Co., Ltd.	42677-326	42677-326-01	1 BOTTLE, GLASS in 1 CARTON (42677-326-01) / 100 mL in 1 BOTTLE, GLASS
ISOFLURANE	isoflurane	LIQUID;INHALATION	216527	ANDA	Shandong New Time Pharmaceutical Co., Ltd.	42677-327	42677-327-01	1 BOTTLE, GLASS in 1 CARTON (42677-327-01) / 250 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;INHALATION			Strength	99.9%
Approval Date:	Nov 4, 2025	TE:	AN	RLD:	No

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