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 |
|---|---|---|---|---|---|
2020/01/27 | 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 | |||
2017/01/09 | Not Applicable | Completed |
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 |
|---|---|---|---|---|---|
| Theophylline Sustained-release Capsules | 国药准字H10960283 | 化学药品 | 胶囊剂 | 8/11/2020 | |
| Theophylline and Glucose Injection | 国药准字H19991403 | 化学药品 | 注射剂 | 1/7/2021 | |
| Theophylline and Glucose Injection | 国药准字H20020499 | 化学药品 | 注射剂 | 4/17/2020 | |
| Theophylline and Glucose Injection | 国药准字H19991405 | 化学药品 | 注射剂 | 12/1/2020 | |
| Theophylline and Glucose Injection | 国药准字H19991404 | 化学药品 | 注射剂 | 1/7/2021 | |
| Theophylline Sustained-release Tablets | 国药准字H51020384 | 化学药品 | 片剂(缓释片) | 9/29/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H14020586 | 化学药品 | 片剂 | 8/18/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H20033244 | 化学药品 | 片剂 | 4/15/2024 | |
| Theophylline Sustained-release Tablets | 国药准字H23021113 | 化学药品 | 片剂(缓释) | 4/20/2020 | |
| Theophylline Sustained-release Tablets | 国药准字H31020344 | 化学药品 | 片剂(缓释) | 3/11/2020 |
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 |
|---|---|---|---|---|---|
| NUELIN SR 250 theophylline 250mg tablet | 46069 | Medicine | A | 8/11/1993 |
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