MedPath

Phenylacetic acid

Generic Name
Phenylacetic acid
Brand Names
Ammonul
Drug Type
Small Molecule
Chemical Formula
C8H8O2
CAS Number
103-82-2
Unique Ingredient Identifier
ER5I1W795A

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

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
No NMPA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
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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