Overview
Tuberculin Purified Protein Derivative (PPD) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The diagnostic test is commonly referred to as the Mantoux test which serves to minimize the risk of transmission of infection with Mycobacterium tuberculosis through early diagnosis and appropriate therapeutic intervention. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis. It is included in the World Health Organization's List of Essential Medicines.
Indication
Indicated as a diagnostic agent in Mantoux Test used to detect infection with Mycobacterium tuberculosis.
Associated Conditions
- Tuberculosis (TB)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/12 | Phase 3 | Recruiting | |||
2023/02/28 | Phase 4 | Active, not recruiting | |||
2021/08/31 | Early Phase 1 | Completed | |||
2001/08/31 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| TYA Pharmaceuticals | 64725-0104 | INTRADERMAL | 5 [iU] in 0.1 mL | 7/9/2015 | |
| A-S Medication Solutions | 50090-1668 | INTRADERMAL | 5 [iU] in 0.1 mL | 11/9/2021 | |
| Sanofi Pasteur Inc. | 49281-752 | INTRADERMAL | 5 [iU] in 0.1 mL | 1/25/2024 | |
| Apex Energetics Inc. | 63479-1412 | SUBLINGUAL | 30 [hp_X] in 1 mL | 4/22/2025 | |
| Physicians Total Care, Inc. | 54868-2972 | INTRADERMAL | 5 [iU] in 0.1 mL | 5/22/2013 | |
| A-S Medication Solutions | 50090-0261 | INTRADERMAL | 5 [iU] in 0.1 mL | 11/9/2021 | |
| Par Pharmaceutical, Inc. | 42023-104 | INTRADERMAL | 5 [iU] in 0.1 mL | 11/1/2017 | |
| A-S Medication Solutions | 50090-1336 | INTRADERMAL | 5 [iU] in 0.1 mL | 11/1/2017 | |
| Apex Energetics Inc. | 63479-1412 | SUBLINGUAL | 30 [hp_X] in 1 mL | 5/15/2025 |
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 |
|---|---|---|---|---|---|
| TUBERCULIN PPD RT 23 AJV | SIN09944P | INJECTION | 0.4 mcg/ml | 8/19/1998 | |
| INFANRIX HEXA VACCINE | SIN12288P | INJECTION | 10 mcg/0.5 ml | 5/7/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Purified Protein Derivative of Tuberculin(TB-PPD) | 国药准字S10960017 | 生物制品 | 注射剂 | 6/4/2021 | |
| Purified Protein Derivative of Tuberculin(TB-PPD) | 国药准字S10960016 | 生物制品 | 注射剂 | 6/4/2021 | |
| Purified Protein Derivative of Tuberculin(TB-PPD) | 国药准字S10960018 | 生物制品 | 注射剂 | 10/30/2020 |
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 |
|---|---|---|---|---|---|
| TUBERSOL tuberculin purified protein derivative (mantoux) diagnostic antigen vial | 28624 | Medicine | A | 11/4/1991 |
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