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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-815
Application NumberANDA212494
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2022
FDA Product Classification
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