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 |
|---|---|---|---|---|---|
2011/02/11 | Phase 2 | Completed | Liaoning University of Traditional Chinese Medicine | ||
2010/12/20 | Phase 1 | Completed | |||
2010/05/28 | Phase 2 | Completed | |||
2010/02/10 | Phase 2 | Completed | |||
2009/11/23 | Phase 1 | Completed | |||
2009/09/24 | Phase 1 | Completed | |||
2009/05/05 | Not Applicable | UNKNOWN | |||
2008/10/24 | Phase 1 | Completed | |||
2008/09/22 | Phase 4 | Completed | |||
2008/05/05 | Not Applicable | Completed | Hospital Universitari Son Dureta |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Carilion Materials Management | 68151-4210 | ORAL | 600 mg in 1 1 | 11/8/2014 | |
| Golden State Medical Supply, Inc. | 51407-318 | ORAL | 400 mg in 1 1 | 1/31/2024 | |
| Tris Pharma Inc | 27808-033 | ORAL | 80 mg in 15 mL | 9/17/2018 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-380 | ORAL | 400 mg in 1 1 | 6/30/2019 | |
| Nostrum Laboratories, Inc. | 29033-002 | ORAL | 600 mg in 1 1 | 1/21/2020 | |
| PAI Holdings, LLC | 0121-0820 | ORAL | 80 mg in 15 mL | 8/11/2023 | |
| Endo Pharmaceuticals, Inc. | 52244-400 | ORAL | 400 mg in 1 1 | 8/30/2017 | |
| Marlex Pharmaceuticals Inc | 10135-604 | ORAL | 80 mg in 15 mL | 10/25/2019 | |
| Alembic Pharmaceuticals Limited | 46708-025 | ORAL | 300 mg in 1 1 | 1/11/2023 | |
| Bionpharma Inc., | 69452-267 | ORAL | 300 mg in 1 1 | 10/12/2023 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ELIXIR DE THEOPHYLLINE | laboratoire atlas inc | 00627410 | Elixir - Oral | 80 MG / 15 ML | 12/31/1985 |
| THEOLAIR SR TAB 250MG | 3 m pharmaceuticals, a division of 3 m canada company | 01966251 | Tablet (Extended-Release) - Oral | 250 MG / TAB | 12/31/1993 |
| THEO ER | aa pharma inc | 02360101 | Tablet (Extended-Release) - Oral | 400 MG | 6/23/2011 |
| THEOPHYLLINE SUSTAINED RELEASE TAB 100MG | forest labs inc | 00631698 | Tablet (Extended-Release) - Oral | 100 MG / TAB | 12/31/1985 |
| SLO-BID 50 | aventis pharma inc | 01926616 | Capsule (Sustained-Release) - Oral | 50 MG | 12/31/1988 |
| THEOCHRON SRT 100MG | forest labs inc | 00631698 | Tablet (Extended-Release) - Oral | 100 MG / TAB | 12/31/1985 |
| BRONCHYL SYR | carmaran ltée | 00545090 | Liquid - Oral | 40 MG / 10 ML | 12/31/1982 |
| THEOLAIR SR TAB 200MG | 3 m pharmaceuticals, a division of 3 m canada company | 01966243 | Tablet (Extended-Release) - Oral | 200 MG / TAB | 12/31/1993 |
| THEO-DUR 300 MG | astrazeneca canada inc | 00461008 | Tablet (Extended-Release) - Oral | 300 MG / SRT | 12/31/1979 |
| THEOCHRON SRT 300MG | forest labs inc | 00599905 | Tablet (Extended-Release) - Oral | 300 MG / TAB | 12/31/1985 |
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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