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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 205230


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NDA 205230 describes BUTALBITAL, ASPIRIN AND CAFFEINE, which is a drug marketed by Lgm Pharma, Mpp Pharma, Watson Labs, Actavis Elizabeth, Fosun Pharma, Halsey, Hikma Intl Pharms, Ivax Pharms, Puracap Pharm, Quantum Pharmics, and Strides Pharma, and is included in twelve NDAs. It is available from three suppliers. Additional details are available on the BUTALBITAL, ASPIRIN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ASPIRIN AND CAFFEINE is aspirin; butalbital; caffeine. There are twenty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.
Summary for 205230
Tradename:BUTALBITAL, ASPIRIN AND CAFFEINE
Applicant:Lgm Pharma
Ingredient:aspirin; butalbital; caffeine
Patents:0
Pharmacology for NDA: 205230
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectCentral Nervous System Stimulation
Decreased Platelet Aggregation
Decreased Prostaglandin Production
Suppliers and Packaging for NDA: 205230
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ASPIRIN AND CAFFEINE aspirin; butalbital; caffeine CAPSULE;ORAL 205230 ANDA LGM PHARMA SOLUTIONS, LLC 79739-7192 79739-7192-1 100 CAPSULE in 1 BOTTLE (79739-7192-1)
BUTALBITAL, ASPIRIN AND CAFFEINE aspirin; butalbital; caffeine CAPSULE;ORAL 205230 ANDA LGM PHARMA SOLUTIONS, LLC 79739-7192 79739-7192-5 500 CAPSULE in 1 BOTTLE (79739-7192-5)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength500MG;50MG;40MG
Approval Date:Oct 18, 2021TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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