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 |
|---|---|---|---|---|---|
2013/02/26 | Phase 1 | Withdrawn | |||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 | |||
2011/02/11 | Phase 2 | Completed | Liaoning University of Traditional Chinese Medicine |
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 |
|---|---|---|---|---|---|
| Theophylline Sustained-release Tablets | 国药准字H23020298 | 化学药品 | 片剂 | 6/19/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H21021268 | 化学药品 | 片剂(缓释) | 5/12/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H43020832 | 化学药品 | 片剂 | 11/21/2019 | |
| Theophylline Sustained-release Tablets | 国药准字H23021082 | 化学药品 | 片剂(素片) | 8/31/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H22022682 | 化学药品 | 片剂(缓释) | 7/29/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H13021031 | 化学药品 | 片剂 | 8/19/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H37021127 | 化学药品 | 片剂 | 4/13/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H11020150 | 化学药品 | 片剂 | 11/26/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H13021032 | 化学药品 | 片剂 | 8/19/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H22020485 | 化学药品 | 片剂 | 5/22/2020 |
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. | |||||
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