Data updated: Mar 10, 2026
AMINOPHYLLINE
AMINOPHYLLINE
Approved 1975-11-26
22
Indications
--
Phase 3 Trials
50
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1975-11-26
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, DELAYED RELEASE, TABLET, INJECTABLE, SOLUTION
Companies
VALE VALEANT PHARM INTL IMPAX LABS ANI PHARMS VANGARD SMITH AND NEPHEW Teva KV PHARM INTL MEDICATION DURAMED PHARMS BARR HALSEY ROXANE MORTON GROVE ABRAXIS PHARM PUREPAC PHARM WATSON LABS PHARMA SERVE NY LYPHOMED Hikma VINTAGE PHARMS ASCOT LUITPOLD CHARTWELL MOLECULAR TABLICAPS KING PHARMS ELKINS SINN AM REGENT PAL PAK PANRAY Pfizer
Active Ingredient: AMINOPHYLLINE
Website: ↗
AMINOPHYLLINE Approval History
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What AMINOPHYLLINE Treats
22 FDA approvalsOriginally approved for its first indication in 1975 . Covers 22 distinct patient populations.
- Other (22)
Other
(22 approvals)- • Approved indication (Nov 1975)
- • Approved indication (Dec 1975)
- • Approved indication (Mar 1976)
- • Approved indication (Mar 1976)
- • Approved indication (May 1976)
- • Approved indication (Jun 1976)
- • Approved indication (Oct 1976)
- • Approved indication (Oct 1976)
- • Approved indication (Dec 1976)
- • Approved indication (Feb 1981)
- • Approved indication (Apr 1981)
- • Approved indication (Aug 1981)
- • Approved indication (Nov 1981)
- • Approved indication (Feb 1982)
- • Approved indication (Feb 1982)
- • Approved indication (Jul 1982)
- • Approved indication (Mar 1983)
- • Approved indication (Aug 1983)
- • Approved indication (Oct 1983)
- • Approved indication (Oct 1983)
- • Approved indication (Dec 1983)
- • Approved indication (Sep 1991)
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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.
AMINOPHYLLINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.