Overview
A methylxanthine derivative from tea with diuretic, smooth muscle relaxant, bronchial dilation, cardiac and central nervous system stimulant activities. Mechanistically, theophylline acts as a phosphodiesterase inhibitor, adenosine receptor blocker, and histone deacetylase activator. Theophylline is marketed under several brand names such as Uniphyl and Theochron, and it is indicated mainly for asthma, bronchospasm, and COPD.
Indication
For the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, such as emphysema and chronic bronchitis.
Associated Conditions
- Asthma
- Bronchitis
- Bronchoconstriction
- Bronchospasm
- Chronic Obstructive Pulmonary Disease (COPD)
- Chronic bronchial inflammation
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/06 | Phase 4 | Completed | Damanhour Teaching Hospital | ||
2020/01/27 | Phase 2 | ENROLLING_BY_INVITATION | Ashley Shoemaker | ||
2019/11/04 | Not Applicable | UNKNOWN | |||
2019/06/19 | Phase 2 | Completed | |||
2019/06/12 | Phase 3 | Completed | |||
2019/03/28 | Not Applicable | UNKNOWN | |||
2019/01/14 | N/A | Completed | Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella | ||
2018/10/24 | Phase 4 | Recruiting | |||
2017/04/14 | Not Applicable | Completed | |||
2017/01/24 | Phase 2 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Chartwell RX, LLC | 62135-457 | ORAL | 300 mg in 1 1 | 2/13/2023 | |
| Carilion Materials Management | 68151-1393 | ORAL | 300 mg in 1 1 | 12/5/2016 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-721 | ORAL | 300 mg in 1 1 | 6/4/2021 | |
| State of Florida DOH Central Pharmacy | 53808-0982 | ORAL | 300 mg in 1 1 | 4/24/2014 | |
| Physicians Total Care, Inc. | 54868-1461 | ORAL | 100 mg in 1 1 | 9/23/2011 | |
| Golden State Medical Supply, Inc. | 51407-319 | ORAL | 600 mg in 1 1 | 1/31/2024 | |
| Endo Pharmaceuticals, Inc. | 52244-200 | ORAL | 200 mg in 1 1 | 8/30/2017 | |
| Amneal Pharmaceuticals NY LLC | 60219-2045 | ORAL | 300 mg in 1 1 | 3/22/2023 | |
| Nostrum Laboratories, Inc. | 29033-060 | ORAL | 450 mg in 1 1 | 8/15/2023 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-742 | ORAL | 450 mg in 1 1 | 6/27/2022 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NUELIN SR 250 theophylline 250mg tablet | 46069 | Medicine | A | 8/11/1993 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TEVA-THEOPHYLLINE SR | teva canada limited | 02230086 | Tablet (Extended-Release) - Oral | 200 MG | 12/19/1996 |
| THEOPHYLLINE SUSTAINED RELEASE TAB 200MG | forest labs inc | 00631701 | Tablet (Extended-Release) - Oral | 200 MG / TAB | 12/31/1985 |
| UNIPHYL | elvium life sciences | 02014165 | Tablet (Extended-Release) - Oral | 400 MG | 12/31/1987 |
| THEOPHYLLINE 0.8MG/ML IN 5% DEXTROSE INJ | hospira healthcare ulc | 00640093 | Solution - Intravenous | 0.8 MG / ML | 12/31/1986 |
| THEOPHYLLINE ELX | technilab pharma inc. | 00532223 | Elixir - Oral | 80 MG / 15 ML | 12/31/1981 |
| AA-THEO LA | aa pharma inc | 00692700 | Tablet (Extended-Release) - Oral | 300 MG | 12/31/1993 |
| THEOCHRON SRT 200MG | forest labs inc | 00631701 | Tablet (Extended-Release) - Oral | 200 MG / TAB | 12/31/1985 |
| TEDRAL TAB | parke-davis division, warner-lambert canada inc. | 00476846 | Tablet - Oral | 118 MG / TAB | 12/31/1981 |
| TEVA-THEOPHYLLINE SR | teva canada limited | 02230087 | Tablet (Extended-Release) - Oral | 300 MG | 4/16/1998 |
| THEO ER | aa pharma inc | 02360128 | Tablet (Extended-Release) - Oral | 600 MG | 6/23/2011 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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