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Details for New Drug Application (NDA): 017624

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NDA 017624 describes FORANE, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the FORANE profile page.

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

Summary for NDA: 017624

Tradename:
FORANE
Applicant:
Baxter Hlthcare
Ingredient:
isoflurane
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 017624

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 017624

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORANE
isoflurane
LIQUID;INHALATION 017624 NDA Baxter Healthcare Corporation 10019-360 10019-360-40 6 BOTTLE, GLASS in 1 PACKAGE (10019-360-40) > 100 mL in 1 BOTTLE, GLASS
FORANE
isoflurane
LIQUID;INHALATION 017624 NDA Baxter Healthcare Corporation 10019-360 10019-360-60 6 BOTTLE, GLASS in 1 PACKAGE (10019-360-60) > 250 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;INHALATIONStrength99.9%
Approval Date:Approved Prior to Jan 1, 1982TE:ANRLD:Yes

Expired Orange Book Patents for NDA: 017624

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare
FORANE
isoflurane
LIQUID;INHALATION017624-001Approved Prior to Jan 1, 19823,535,388► subscribe
Baxter Hlthcare
FORANE
isoflurane
LIQUID;INHALATION017624-001Approved Prior to Jan 1, 19823,535,425► subscribe
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