Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Carnegie Pharmaceuticals, LLC
079839141
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carnegie Pharmaceuticals, LLC
Carnegie Pharmaceuticals, LLC
Carnegie Pharmaceuticals, LLC
079839141
Products2
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
80005-129Application Number
ANDA213928Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 20, 2023Aminocaproic acidActive
Code: U6F3787206Class: ACTIBQuantity: 1000 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
AMINOCAPROIC ACID
Product Details
NDC Product Code
80005-128Application Number
ANDA213928Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 20, 2023Aminocaproic acidActive
Code: U6F3787206Class: ACTIBQuantity: 500 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT