Overview
An ethanolamine derivative that is an adrenergic alpha agonist. It is used as a vasoconstrictor agent in the treatment of hypotension.
Indication
For the treatment of symptomatic orthostatic hypotension (OH).
Associated Conditions
- Symptomatic Orthostatic Hypotension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/08 | Phase 2 | Not yet recruiting | |||
2024/03/20 | Phase 2 | Recruiting | |||
2024/02/07 | Not Applicable | Not yet recruiting | |||
2024/01/19 | Not Applicable | Not yet recruiting | |||
2023/10/19 | Not Applicable | Recruiting | |||
2023/05/03 | Phase 4 | Recruiting | James J. Peters Veterans Affairs Medical Center | ||
2023/04/07 | Not Applicable | Recruiting | China National Center for Cardiovascular Diseases | ||
2023/03/21 | Phase 2 | Completed | Noha Mansour | ||
2022/09/22 | Not Applicable | Completed | |||
2022/03/18 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novugen Pharma (USA) LLC | 82293-004 | ORAL | 5 mg in 1 1 | 10/20/2023 | |
| McKesson Corporation DBA SKY Packaging | 63739-145 | ORAL | 5 mg in 1 1 | 12/13/2023 | |
| Novugen Pharma (USA) LLC | 82293-003 | ORAL | 2.5 mg in 1 1 | 10/20/2023 | |
| Proficient Rx LP | 71205-906 | ORAL | 10 mg in 1 1 | 4/1/2022 | |
| Novugen Pharma (USA) LLC | 82293-005 | ORAL | 10 mg in 1 1 | 10/20/2023 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8443 | ORAL | 2.5 mg in 1 1 | 8/8/2023 | |
| Cardinal Health 107, LLC | 55154-4174 | ORAL | 10 mg in 1 1 | 3/2/2023 | |
| Carilion Materials Management | 68151-2958 | ORAL | 5 mg in 1 1 | 1/28/2016 | |
| Zydus Lifesciences Limited | 70771-1595 | ORAL | 2.5 mg in 1 1 | 11/1/2023 | |
| Cardinal Health 107, LLC | 55154-5696 | ORAL | 5 mg in 1 1 | 1/25/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GUTRON TABLET 5 mg | SIN11500P | TABLET | 5 mg | 4/28/2001 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Midodrine Hydrochloride Tablets | 国药准字H20060837 | 化学药品 | 片剂(素片) | 12/18/2020 | |
| Midodrine Hydrochloride Tablets | 国药准字H20060551 | 化学药品 | 片剂 | 11/10/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MIDODRINE ANS midodrine hydrochloride 2.5 mg immediate release tablet blister pack | 309181 | Medicine | A | 12/18/2019 | |
| MIDODRINE ANS midodrine hydrochloride 5 mg immediate release tablet blister pack | 309182 | Medicine | A | 12/18/2019 | |
| VASODRINE midodrine hydrochloride 5 mg immediate release tablet blister pack | 309184 | Medicine | A | 12/18/2019 | |
| MIDODRINE SCP midodrine hydrochloride 5 mg immediate release tablet blister pack | 309180 | Medicine | A | 12/18/2019 | |
| Midodrine Hydrochloride 10 mg tablet bottle | 387795 | Medicine | A | 5/3/2022 | |
| VASODRINE midodrine hydrochloride 2.5 mg immediate release tablet blister pack | 309183 | Medicine | A | 12/18/2019 | |
| Midodrine Hydrochloride 5 mg tablet bottle | 387794 | Medicine | A | 5/3/2022 | |
| Midodrine Hydrochloride 2.5 mg tablet bottle | 387793 | Medicine | A | 5/3/2022 | |
| MIDODRINE SCP midodrine hydrochloride 2.5 mg immediate release tablet blister pack | 309179 | Medicine | A | 12/18/2019 |
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