Data updated: Mar 10, 2026
BUTALBITAL, ASPIRIN AND CAFFEINE
ASPIRIN
Approved 1979-02-21
9
Indications
--
Phase 3 Trials
47
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1979-02-21
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
Companies
FOSUN PHARMA PURACAP PHARM HALSEY Teva STRIDES PHARMA Hikma LGM PHARMA IVAX PHARMS WATSON LABS MPP PHARMA QUANTUM PHARMICS
Website: ↗
BUTALBITAL, ASPIRIN AND CAFFEINE Approval History
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What BUTALBITAL, ASPIRIN AND CAFFEINE Treats
9 FDA approvalsOriginally approved for its first indication in 1979 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Feb 1979)
- • Approved indication (Jun 1979)
- • Approved indication (Jul 1979)
- • Approved indication (Apr 1980)
- • Approved indication (Jul 1980)
- • Approved indication (Jun 1982)
- • Approved indication (Jun 2007)
- • Approved indication (Sep 2016)
- • Approved indication (Oct 2021)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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 AND CAFFEINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.