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Data updated: Mar 10, 2026

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

ASPIRIN Cyclooxygenase Inhibitors
Immunology Approved 1995-08-31
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Prescription
First Approved
1995-08-31
Routes
ORAL
Dosage Forms
CAPSULE

Companies

STEVENS J WATSON LABS Dr. Reddy's LGM PHARMA NOVITIUM PHARMA
Active Ingredient: ASPIRIN , BUTALBITAL , CAFFEINE , CODEINE PHOSPHATE

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE Approval History

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What BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE Treats

1 indications

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pain
Source: FDA Label

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE Competitors

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4 other drugs also target AMPA receptor. Compare mechanisms, indications, and trial activity.

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Hikma
PERAMPANEL
Teva
FYCOMPA
CATALYST PHARMS
QSYMIA
VIVUS LLC
Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (AMPA receptor). Earlier expiry dates signal biosimilar/generic opportunities.

Drugs Similar to BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACUVAIL
KETOROLAC TROMETHAMINE
1 shared
AbbVie
Shared indications:
Pain
BELBUCA
BUPRENORPHINE HYDROCHLORIDE
1 shared
BDSI
Shared indications:
Pain
BUPRENORPHINE
BUPRENORPHINE
1 shared
WATSON LABS TEVA
Shared indications:
Pain
BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE
1 shared
Hikma
Shared indications:
Pain
BUTORPHANOL TARTRATE PRESERVATIVE FREE
BUTORPHANOL TARTRATE
1 shared
Pfizer
Shared indications:
Pain
BUTRANS
BUPRENORPHINE
1 shared
PURDUE PHARMA LP
Shared indications:
Pain
BYQLOVI
CLOBETASOL PROPIONATE
1 shared
HARROW EYE
Shared indications:
Pain
CALDOLOR
IBUPROFEN
1 shared
CUMBERLAND PHARMS
Shared indications:
Pain
CATAFLAM
DICLOFENAC POTASSIUM
1 shared
AMICI PHARMA
Shared indications:
Pain
COMBOGESIC IV
ACETAMINOPHEN
1 shared
Hikma
Shared indications:
Pain
DICLOFENAC POTASSIUM
DICLOFENAC POTASSIUM
1 shared
INGENUS PHARMS LLC
Shared indications:
Pain
DIFLUNISAL
DIFLUNISAL
1 shared
Teva
Shared indications:
Pain
DIFLUPREDNATE
DIFLUPREDNATE
1 shared
Cipla
Shared indications:
Pain
DILAUDID
HYDROMORPHONE HYDROCHLORIDE
1 shared
Fresenius Kabi
Shared indications:
Pain
DUREZOL
DIFLUPREDNATE
1 shared
Novartis
Shared indications:
Pain
EC-NAPROSYN
NAPROXEN
1 shared
ATNAHS PHARMA US
Shared indications:
Pain
EXPAREL
BUPIVACAINE
1 shared
PACIRA PHARMS INC
Shared indications:
Pain
FLECTOR
DICLOFENAC EPOLAMINE
1 shared
IBSA
Shared indications:
Pain
GLYDO
LIDOCAINE HYDROCHLORIDE
1 shared
SAGENT PHARMS INC
Shared indications:
Pain
HYDROCODONE BITARTRATE AND ASPIRIN
ASPIRIN
1 shared
LGM PHARMA
Shared indications:
Pain
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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE FDA Label Details

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Indications & Usage

Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin

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Data Sources

FDA Approval: ANDA074951 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.