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AMINOCAPROIC ACID

Aminocaproic Acid Tablets, USPRx only

Approved
Approval ID

871ec401-30f8-4154-a16e-b82dc1e04b49

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 20, 2023

Manufacturers
FDA

Carnegie Pharmaceuticals, LLC

DUNS: 079839141

Products 2

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 Code80005-129
Application NumberANDA213928
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMINOCAPROIC ACID
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2023
FDA Product Classification

INGREDIENTS (5)

AMINOCAPROIC ACIDActive
Quantity: 1000 mg in 1 1
Code: U6F3787206
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

AMINOCAPROIC ACID

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code80005-128
Application NumberANDA213928
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMINOCAPROIC ACID
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2023
FDA Product Classification

INGREDIENTS (5)

AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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AMINOCAPROIC ACID - FDA Drug Approval Details