Overview
Phenylacetic acid is an organic compound containing a phenyl functional group and a carboxylic acid functional group. It is a white solid with a disagreeable odor. Because it is used in the illicit production of phenylacetone (used in the manufacture of substituted amphetamines), it is subject to controls in countries including the United States and China.
Indication
For use as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.
Associated Conditions
- Hyperammonaemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2019/11/07 | Phase 1 | Completed | |||
2009/09/16 | Phase 1 | Completed | |||
2000/02/25 | Phase 2 | Completed | National Center for Research Resources (NCRR) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
MAIA PHARMACEUTICALS | 70511-102 | INTRAVENOUS | 100 mg in 1 mL | 6/24/2021 | |
Oceanside Pharmaceuticals | 68682-001 | INTRAVENOUS | 100 mg in 1 mL | 12/1/2020 | |
Mylan Institutional LLC | 67457-844 | INTRAVENOUS | 100 mg in 1 mL | 3/16/2021 | |
Woodward Pharma Services LLC | 69784-811 | INTRAVENOUS | 100 mg in 1 mL | 12/15/2021 | |
Bausch Health US LLC | 0187-0010 | INTRAVENOUS | 100 mg in 1 mL | 12/1/2020 | |
Ailex Pharmaceuticals, LLC | 70556-100 | INTRAVENOUS | 100 mg in 1 mL | 4/20/2018 | |
Zydus Pharmaceuticals USA Inc. | 70710-1926 | INTRAVENOUS | 100 mg in 1 mL | 10/30/2023 | |
Navinta LLC | 68475-001 | INTRAVENOUS | 100 mg in 1 mL | 12/2/2022 | |
Ucyclyd Pharma Inc. | 62592-720 | INTRAVENOUS | 100 mg in 1 mL | 1/12/2018 | |
FOSUN PHARMA USA INC | 72266-236 | INTRAVENOUS | 100 mg in 1 mL | 10/21/2021 |
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 |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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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