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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 074416

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NDA 074416 describes ISOFLURANE, which is a drug marketed by Halocarbon Prods, Hospira, Piramal Critical, Piramal Pharma, and Watson Labs Inc, and is included in five NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the isoflurane profile page.

Summary for 074416

Tradename:	ISOFLURANE
Applicant:	Piramal Critical
Ingredient:	isoflurane
Patents:	0

Pharmacology for NDA: 074416

Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for 074416

Anesthetics, Inhalation

Suppliers and Packaging for NDA: 074416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOFLURANE	isoflurane	LIQUID;INHALATION	074416	ANDA	Piramal Critical Care Inc	66794-011	66794-011-10	100 mL in 1 BOTTLE, GLASS (66794-011-10)
ISOFLURANE	isoflurane	LIQUID;INHALATION	074416	ANDA	Piramal Critical Care Inc	66794-011	66794-011-25	250 mL in 1 BOTTLE, GLASS (66794-011-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;INHALATION			Strength	99.9%
Approval Date:	Sep 30, 1994	TE:	AN	RLD:	No

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