apixaban Oral Tablet

Brand(s)
Eliquis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-09-10)
Oldest Current Product
2012-12-28
License(s)
NDA
RxNORM
ORAL TABLET\APIXABAN
FDAOB
ORAL\TABLET\APIXABAN
SPL Active
ORAL\TABLET, FILM COATED\APIXABAN
SPL Moiety
ORAL\TABLET, FILM COATED\APIXABAN

product(s) by strength(s)

apixaban 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000030893EliquisNDAE.R. Squibb & Sons, L.L.C.2012-12-28APIXABANORALTABLET, FILM COATEDNDA202155e9481622-7cc6-418a-acb6-c5450daae9b0

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551540612EliquisNDACardinal Health2012-12-28APIXABANORALTABLET, FILM COATED000030893NDA202155a454cd24-0c6d-46e8-b1e4-197388606175

apixaban 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000030894EliquisNDAE.R. Squibb & Sons, L.L.C.2012-12-28APIXABANORALTABLET, FILM COATEDNDA202155e9481622-7cc6-418a-acb6-c5450daae9b0

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202155ELIQUISBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE2012-12-28p6967208, TREATMENT OF DEEP VEIN THROMBOSIS (DVT)/ TREATMENT OF PULMONARY EMBOLISM (PE)/ REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM/ REDUCING THE RISK OF STROKE/ PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)/ PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM/ REDUCE THE RISK OF RECURRENT PULMONARY EMBOLISM/ PROPHYLAXIS OF PULMONARY EMBOLISM/ REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT), SUBSTANCE
p6413980, TREATMENT OF DEEP VEIN THROMBOSIS (DVT)/ TREATMENT OF PULMONARY EMBOLISM (PE)/ REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM/ PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM, SUBSTANCE
PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT) WHICH MAY LEAD TO PULMONARY EMBOLISM (PE) [2017-03-03]
TREATMENT OF PULMONARY EMBOLISM [2017-08-21]
NEW CHEMICAL ENTITY [2017-12-28]
INDICATED TO REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) FOLLOWING INITIAL THERAPY [2017-08-21]
INDICATED FOR THE TREATMENT OF DEEP VEIN THROMBOSIS (DVT) [2017-08-21]
NDA202155_001, NDA202155_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202155_001RXAPIXABAN (2.5MG)ORALTABLETFalse2012-12-28ELIQUIS
2NDA202155_002RXAPIXABAN (5MG)ORALTABLETTrue2012-12-28ELIQUIS

patent(s)

#idexpiration dateapplication(s)
1p6413980 (view patent)2019-12-22NDA202155
2p6967208 (view patent)2023-02-03NDA202155

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a454cd24-0c6d-46e8-b1e4-197388606175 (view SPL)These highlights do not include all the information needed to use ELIQUIS safely and effectively. See full prescribing information for ELIQUIS. ELIQUIS (apixaban) tablets for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionCardinal HealthREPACK2015-04-012551540612
2e9481622-7cc6-418a-acb6-c5450daae9b0 (view SPL)These highlights do not include all the information needed to use ELIQUIS safely and effectively. See full prescribing information for ELIQUIS. ELIQUIS (apixaban) tablets, for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-09-107000030893, 000030894

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