AMICAR
AMICAR (aminocaproic acid) Oral Solution and Tablets
Approved
Approval ID
2238c70f-b0b5-4755-896b-45b28777b217
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2022
Manufacturers
FDA
Akorn Operating Company LLC
DUNS: 117693100
Products 3
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 Code49411-052
Application NumberNDA015230
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJune 28, 2022
Generic NameAminocaproic Acid
INGREDIENTS (8)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 0.25 g in 1 mL
Code: U6F3787206
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
Aminocaproic Acid
PRODUCT DETAILS
NDC Product Code49411-050
Application NumberNDA015197
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJune 28, 2022
Generic NameAminocaproic Acid
INGREDIENTS (5)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Aminocaproic Acid
PRODUCT DETAILS
NDC Product Code49411-051
Application NumberNDA015197
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJune 28, 2022
Generic NameAminocaproic Acid
INGREDIENTS (5)
AMINOCAPROIC ACIDActive
Quantity: 1000 mg in 1 1
Code: U6F3787206
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT