MedPath

Aminocaproic acid

Aminocaproic Acid Oral Solution, USP

Approved
Approval ID

afffd309-3819-07c6-e053-2995a90a948b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 17, 2022

Manufacturers
FDA

TruPharma LLC

DUNS: 078533947

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aminocaproic Acid

PRODUCT DETAILS

NDC Product Code52817-815
Application NumberANDA212494
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 17, 2022
Generic NameAminocaproic Acid

INGREDIENTS (9)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 0.25 g in 1 mL
Code: U6F3787206
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Aminocaproic acid - FDA Drug Approval Details