6-Aminocaproic Acid Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
American Regent, Inc. (2014-02-24)
Oldest Current Product
1990-09-30
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\6-AMINOCAPROIC ACID
FDAOB
INJECTION\INJECTION\AMINOCAPROIC ACID\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\AMINOCAPROIC ACID
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\AMINOCAPROIC ACID

product(s) by strength(s)

6-aminocaproic acid 250 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005179120ANDAAmerican Regent, Inc.1990-09-30AMINOCAPROIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA071192f4f65667-c349-420b-b7b7-f20f3a4e4d4e

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070010AMINOCAPROIC ACID IN PLASTIC CONTAINERHOSPIRA INC1987-03-09ANDA070010_0016-Aminocaproic Acid Injection
2ANDA070522AMINOCAPROIC ACIDTrueABRAXIS PHARMACEUTICAL PRODUCTS1986-06-17ANDA070522_0016-Aminocaproic Acid Injection
3ANDA070888AMINOCAPROIC ACIDTrueHOSPIRA INC1988-06-16ANDA070888_0016-Aminocaproic Acid Injection
4ANDA071192AMINOCAPROIC ACIDLUITPOLD PHARMACEUTICALS INC1987-12-01ANDA071192_0016-Aminocaproic Acid Injection
5NDA015229AMICARTrueCLOVER PHARMACEUTICALS CORPNDA015229_0026-Aminocaproic Acid Injection
6NDA018590AMINOCAPROIC ACIDTrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1982-10-29NDA018590_0016-Aminocaproic Acid Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070010_001RXAMINOCAPROIC ACID (250MG/ML)INJECTIONTrueAP1987-03-09AMINOCAPROIC ACID IN PLASTIC CONTAINER
2ANDA070522_001discontinuedAMINOCAPROIC ACID (250MG/ML)INJECTIONFalse1986-06-17AMINOCAPROIC ACID
3ANDA070888_001discontinuedAMINOCAPROIC ACID (250MG/ML)INJECTIONFalse1988-06-16AMINOCAPROIC ACID
4ANDA071192_001RXAMINOCAPROIC ACID (250MG/ML)INJECTIONFalseAP1987-12-01AMINOCAPROIC ACID
5NDA015229_002discontinuedAMINOCAPROIC ACID (250MG/ML)INJECTIONFalseAMICAR
6NDA018590_001discontinuedAMINOCAPROIC ACID (250MG/ML)INJECTIONFalse1982-10-29AMINOCAPROIC ACID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f4f65667-c349-420b-b7b7-f20f3a4e4d4e (view SPL)AMINOCAPROIC ACID INJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-02-246005179120

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII