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Last Updated: January 23, 2021

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Details for New Drug Application (NDA): 020478

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NDA 020478 describes ULTANE, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. Additional details are available on the ULTANE profile page.

The generic ingredient in ULTANE is sevoflurane. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sevoflurane profile page.
Summary for 020478
Tradename:ULTANE
Applicant:Abbvie
Ingredient:sevoflurane
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020478
Physiological EffectGeneral Anesthesia
Suppliers and Packaging for NDA: 020478
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTANE sevoflurane LIQUID;INHALATION 020478 NDA AbbVie Inc. 0074-4456 0074-4456-04 250 mL in 1 BOTTLE, PLASTIC (0074-4456-04)
ULTANE sevoflurane LIQUID;INHALATION 020478 NDA AbbVie Inc. 0074-4456 0074-4456-51 250 mL in 1 BOTTLE, PLASTIC (0074-4456-51)
Paragraph IV (Patent) Challenges for 020478
Tradename Dosage Ingredient NDA Submissiondate
ULTANE LIQUID;INHALATION sevoflurane 020478

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;INHALATIONStrength100%
Approval Date:Jun 7, 1995TE:ANRLD:Yes

Expired US Patents for NDA 020478

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ULTANE sevoflurane LIQUID;INHALATION 020478-001 Jun 7, 1995   Start Trial   Start Trial
Abbvie ULTANE sevoflurane LIQUID;INHALATION 020478-001 Jun 7, 1995   Start Trial   Start Trial
Abbvie ULTANE sevoflurane LIQUID;INHALATION 020478-001 Jun 7, 1995   Start Trial   Start Trial
Abbvie ULTANE sevoflurane LIQUID;INHALATION 020478-001 Jun 7, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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