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 |
|---|---|---|---|---|---|
2013/12/05 | Not Applicable | Completed | Zhujiang Hospital | ||
2013/02/26 | Phase 1 | Withdrawn | |||
2013/02/20 | Phase 4 | Completed | |||
2013/01/17 | Phase 4 | Completed | The First Affiliated Hospital of Guangzhou Medical University | ||
2012/09/28 | Phase 4 | Completed | |||
2012/09/13 | Phase 4 | Completed | The First Affiliated Hospital of Guangzhou Medical University | ||
2012/05/17 | Phase 4 | Completed | |||
2012/05/16 | Phase 3 | Completed | Hospital Son Espases | ||
2012/03/29 | Phase 1 | Completed | Norwegian Armed Forces Medical Service | ||
2011/08/12 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Nostrum Laboratories, Inc. | 29033-058 | ORAL | 200 mg in 1 1 | 8/15/2023 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-356 | ORAL | 600 mg in 1 1 | 6/30/2019 | |
| Alembic Pharmaceuticals Inc. | 62332-025 | ORAL | 300 mg in 1 1 | 10/1/2021 | |
| Camber Pharmaceuticals, Inc. | 31722-077 | ORAL | 300 mg in 1 1 | 9/20/2023 | |
| Nostrum Laboratories, Inc. | 70408-644 | ORAL | 80 mg in 15 mL | 9/29/2016 | |
| Nostrum Laboratories, Inc. | 29033-057 | ORAL | 100 mg in 1 1 | 8/15/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0316 | ORAL | 300 mg in 1 1 | 5/25/2010 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0038 | ORAL | 80 mg in 15 mL | 1/7/2021 | |
| Endo Pharmaceuticals, Inc. | 52244-100 | ORAL | 100 mg in 1 1 | 8/30/2017 | |
| Chartwell RX, LLC | 62135-556 | ORAL | 80 mg in 15 mL | 10/5/2023 |
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 |
|---|---|---|---|---|---|
| THEOPHYLLINE 80MG/15ML | desbergers ltée, division of technilab inc. | 00261203 | Liquid - Oral | 80 MG / 15 ML | 12/31/1969 |
| THEOPHYLLINE 4MG AND 5% DEXTROSE INJ | baxter corporation | 00828742 | Solution - Intravenous | 4 MG / ML | 12/31/1995 |
| PULMOPHYLLINE ELX | laboratoire riva inc. | 00466409 | Elixir - Oral | 80 MG / 15 ML | 12/31/1979 |
| UNIPHYL | elvium life sciences | 02014181 | Tablet (Extended-Release) - Oral | 600 MG | 12/31/1987 |
| SLO-BID 100 | aventis pharma inc | 01926586 | Capsule (Sustained-Release) - Oral | 100 MG | 12/31/1987 |
| SLO-BID 300 | aventis pharma inc | 01926608 | Capsule (Sustained-Release) - Oral | 300 MG | 12/31/1987 |
| THEOLAIR TAB 125MG | 3 m pharmaceuticals, a division of 3 m canada company | 01966235 | Tablet - Oral | 125 MG | 12/31/1993 |
| TEVA-THEOPHYLLINE SR | teva canada limited | 02230085 | Tablet (Extended-Release) - Oral | 100 MG | 4/16/1998 |
| I D M EXPECTORANT TAB | rougier pharma division of ratiopharm inc | 00334510 | Tablet - Oral | 70 MG / TAB | 12/31/1975 |
| THEOLAIR TAB 250MG | 3 m pharmaceuticals, a division of 3 m canada company | 01966227 | Tablet - Oral | 250 MG | 12/31/1993 |
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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