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FDA Approval

Aminocaproic acid

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Aminocaproic acid(0.25 g in 1 mL)

Products1

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 Code
69238-1596
Application Number
ANDA212780
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 1, 2023
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
Code: U6F3787206Class: ACTIBQuantity: 0.25 g in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
RASPBERRYInactive
Code: 4N14V5R27WClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
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Aminocaproic acid - FDA Approval | MedPath