Data updated: Mar 10, 2026
THEOPHYLLINE
THEOPHYLLINE
Approved 1970-11-21
37
Indications
--
Phase 3 Trials
55
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1970-11-21
- Routes
- ORAL
- Dosage Forms
- ELIXIR, CAPSULE, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, SOLUTION, CAPSULE, SYRUP, SOLUTION, ELIXIR
Companies
ROXANE Novartis HERITAGE PHARMA AVET Pfizer TRIS PHARMA INC INWOOD LABS HALSEY WOCKHARDT AMNEAL ANNORA PHARMA ABLE KV PHARM SUN PHARMA CANADA ZYDUS LIFESCIENCES PRECISION DOSE CENCI GLENMARK PHARMS LTD CENT PHARMS AJANTA PHARMA LTD ALPHARMA US PHARMS PHARM ASSOC CHARTWELL MOLECULAR VELZEN PHARMA PVT BIONPHARMA MPP PHARMA CHARTWELL RX ALEMBIC RHODES PHARMS HARMAN FINOCHEM Teva NOSTRUM PHARMS LLC STRIDES PHARMA SCHERER RP
Active Ingredient: THEOPHYLLINE
Website: ↗
THEOPHYLLINE Approval History
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What THEOPHYLLINE Treats
37 FDA approvalsOriginally approved for its first indication in 1979 . Covers 37 distinct patient populations.
- Other (37)
Other
(37 approvals)- • Approved indication (Feb 1979)
- • Approved indication (Mar 1979)
- • Approved indication (Jul 1979)
- • Approved indication (Jan 1980)
- • Approved indication (Jun 1980)
- • Approved indication (Apr 1982)
- • Approved indication (Jan 1983)
- • Approved indication (Sep 1983)
- • Approved indication (Feb 1985)
- • Approved indication (Oct 1986)
- • Approved indication (Oct 1988)
- • Approved indication (Apr 1990)
- • Approved indication (Nov 1992)
- • Approved indication (Feb 1994)
- • Approved indication (Sep 1994)
- • Approved indication (Apr 1995)
- • Approved indication (Apr 1996)
- • Approved indication (Apr 2004)
- • Approved indication (Apr 2004)
- • Approved indication (Apr 2006)
- • Approved indication (Jul 2010)
- • Approved indication (Oct 2010)
- • Approved indication (Apr 2011)
- • Approved indication (Jun 2012)
- • Approved indication (Dec 2016)
- • Approved indication (Jun 2021)Letter
- • Approved indication (Oct 2022)
- • Approved indication (Jan 2023)
- • Approved indication (Mar 2023)
- • Approved indication (Apr 2023)
- • Approved indication (May 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Oct 2023)
- • Approved indication (May 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Jan 2025)
- • Approved indication (Mar 2025) New
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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.
THEOPHYLLINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.