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Details for New Drug Application (NDA): 020118

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NDA 020118 describes SUPRANE, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from two suppliers. Additional details are available on the SUPRANE profile page.

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

Summary for NDA: 020118

Tradename:
SUPRANE
Applicant:
Baxter Hlthcare
Ingredient:
desflurane
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020118

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 020118

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPRANE
desflurane
LIQUID;INHALATION 020118 NDA Baxter Healthcare Corporation 10019-641 10019-641-24 6 BOTTLE, GLASS in 1 CARTON (10019-641-24) > 240 mL in 1 BOTTLE, GLASS (10019-641-60)
SUPRANE
desflurane
LIQUID;INHALATION 020118 NDA Baxter Healthcare Corporation 10019-641 10019-641-34 6 BOTTLE in 1 CARTON (10019-641-34) > 240 mL in 1 BOTTLE (10019-641-64)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;INHALATIONStrength99.9%
Approval Date:Sep 18, 1992TE:RLD:Yes

Expired Orange Book Patents for NDA: 020118

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare
SUPRANE
desflurane
LIQUID;INHALATION020118-001Sep 18, 19924,762,856*PED► subscribe
Baxter Hlthcare
SUPRANE
desflurane
LIQUID;INHALATION020118-001Sep 18, 19925,617,906*PED► subscribe
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