Adenosine Injection

Brand(s)
Adenoscan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Heritage Pharmaceuticals Inc. (2015-07-16)
Oldest Current Product
2004-06-16
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTION\ADENOSINE
FDAOB
INJECTION\INJECTION\ADENOSINE\rdfq
IV (INFUSION)\SOLUTION\ADENOSINE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ADENOSINE
INTRAVENOUS\INJECTION\ADENOSINE
INTRAVENOUS\SOLUTION\ADENOSINE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ADENOSINE
INTRAVENOUS\INJECTION\ADENOSINE
INTRAVENOUS\SOLUTION\ADENOSINE

product(s) by strength(s)

adenosine 3 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330236UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2015-02-05ADENOSINEINTRAVENOUSINJECTION, SOLUTION1ac3b6d9-7e57-4f27-8f78-436a6a55a9be, a4c5760e-049a-42df-adb2-5f47c3fc89a5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091932ANDAHospira, Inc.2014-03-24ADENOSINEINTRAVENOUSINJECTION, SOLUTIONANDA2038837fd858aa-f4ef-427b-a91c-c860cd27da9d
2174780544ANDAAkorn2014-10-02ADENOSINEINTRAVENOUSINJECTION, SOLUTIONANDA090450f2f1b4c5-1cfe-4b67-95b4-e1a0efc87777
3231550258ANDAHeritage Pharmaceuticals Inc.2014-08-01ADENOSINEINTRAVENOUSINJECTION, SOLUTIONANDA202313df9bed83-6c82-4294-9442-5e7464c3aab1
4231550259ANDAHeritage Pharmaceuticals Inc.2014-08-01ADENOSINEINTRAVENOUSINJECTION, SOLUTIONANDA202313094fbe9b-8833-4eb1-a471-7518e7c23774
5250210307ANDASagent Pharmaceuticals2014-03-28, 2015-09-01ADENOSINEINTRAVENOUSSOLUTIONANDA0902128b9c18db-9b4b-4465-b70c-d2db65c9da10, b2bb0b15-283b-48c6-9401-3280ee21ef7f
6633230651ANDAApp Pharmaceuticals, Llc2005-11-23ADENOSINEINTRAVENOUSINJECTION, SOLUTIONANDA077133e660f71c-35ed-438e-8505-4538f5e925a2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840301ANDAGeneral Injecatables & Vaccines, Inc2014-03-26ADENOSINEINTRAVENOUSINJECTION250210301ANDA078686a707f1be-12cc-411f-a965-fab1b2f29b8e

2 ml adenosine 3 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416113ANDAWest-Ward Pharmaceuticals Corp.2004-06-16ADENOSINEINTRAVENOUSINJECTIONANDA076500b827e3f8-dd63-4e54-90f4-0eded943de9f
2174780542ANDAAkorn2011-03-15ADENOSINEINTRAVENOUSINJECTION, SOLUTIONANDA078076a68d1eff-5cbb-4a6e-98e7-0fb6590ce2a0

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250668ANDARemedyrepack Inc.2013-07-16, 2013-09-24, 2014-03-17, 2014-10-03ADENOSINEINTRAVENOUSINJECTION, SOLUTION174780542ANDA07807621783911-37de-4797-b37d-bdf90030d112, 5581a60e-8e5a-47de-9fb7-31c4fb05ac91, 7ba23241-7d1e-4758-9f8d-5dac87ffb97f, d2a51f9f-d51c-4540-955e-109581f77526
2525840026ANDAGeneral Injecatables & Vaccines, Inc2011-10-05ADENOSINEINTRAVENOUSINJECTION, SOLUTION174780542ANDA078076ee89d63b-123d-4995-b7cc-822c5bee16aa
3548685551ANDAPhysicians Total Care, Inc.2006-03-16ADENOSINEINTRAVENOUSINJECTION, SOLUTION553900067ANDA076404356dac0f-258b-48a4-b7de-528ba2d241c8
4551541279ANDACardinal Health2011-03-17ADENOSINEINTRAVENOUSINJECTION, SOLUTION174780542ANDA0780763c04c033-72e5-469e-83ec-0182cad8be6e

30 ml adenosine 3 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007038777ANDATeva Parenteral Medicines, Inc2013-09-23ADENOSINEINTRAVENOUSINJECTION, SOLUTIONANDA0774251828794c-fb0f-4170-a308-225a21b55f4c

20 ml adenosine 3 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007038776ANDATeva Parenteral Medicines, Inc2013-09-23ADENOSINEINTRAVENOUSINJECTION, SOLUTIONANDA0774251828794c-fb0f-4170-a308-225a21b55f4c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490758AdenoscanNDARemedyrepack Inc.2013-06-27, 2013-10-31ADENOSINEINTRAVENOUSSOLUTION004690871NDA0200598d14be75-5d52-4ff3-9124-6c2f06efef0f, cba928b6-605a-4ca8-b6dc-cf478e9ad4f4
2521250758AdenoscanNDARemedyrepack Inc.2013-06-10ADENOSINEINTRAVENOUSSOLUTION004690871NDA02005991af0499-0efa-45e6-a5f8-2a0c491d1d18
3521250948ANDARemedyrepack Inc.2014-05-23ADENOSINEINTRAVENOUSINJECTION, SOLUTION007038776ANDA077425b7013909-4624-4fb9-b2ef-2ca0d1f793cb

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA076404ADENOSINEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2004-06-16ANDA076404_001Adenosine Prefilled Syringe
2ANDA076500ADENOSINEEUROHEALTH INTERNATIONAL SARL2004-06-16ANDA076500_001Adenosine Prefilled Syringe
3ANDA076501ADENOSINETrueEUROHEALTH INTERNATIONAL SARL2004-06-16ANDA076501_001Adenosine Prefilled Syringe
4ANDA076564ADENOSINETrueTEVA PHARMACEUTICALS USA2004-06-16ANDA076564_001Adenosine Prefilled Syringe
5ANDA077133ADENOSINEFRESENIUS KABI USA LLC2005-04-27ANDA077133_001Adenosine Prefilled Syringe
6ANDA077283ADENOSINEGLAND PHARMA LTD2007-06-14ANDA077283_001Adenosine Prefilled Syringe
7ANDA077425ADENOSINETEVA PHARMACEUTICALS USA2013-08-29ANDA077425_001, ANDA077425_002
8ANDA078076ADENOSINEAKORN INC2008-10-31ANDA078076_001Adenosine Prefilled Syringe
9ANDA078640ADENOSINEMYLAN LABORATORIES LTD2014-03-21ANDA078640_001Adenosine Prefilled Syringe
10ANDA078676ADENOSINETrueTEVA PHARMACEUTICALS USA2008-07-31ANDA078676_001Adenosine Prefilled Syringe
11ANDA078686ADENOSINEMYLAN LABORATORIES LTD2009-05-13ANDA078686_001Adenosine Prefilled Syringe
12ANDA090010ADENOSINELUITPOLD PHARMACEUTICALS INC2009-04-28ANDA090010_001Adenosine Prefilled Syringe
13ANDA090212ADENOSINESAGENT STRIDES LLC2014-03-28ANDA090212_001, ANDA090212_002
14ANDA090220ADENOSINETrueWOCKHARDT LTD2009-07-20ANDA090220_001Adenosine Prefilled Syringe
15ANDA090450ADENOSINEAKORN INC2014-10-02ANDA090450_001, ANDA090450_002
16ANDA202313ADENOSINEEMCURE PHARMACEUTICALS LTD2014-09-15ANDA202313_001, ANDA202313_002
17ANDA203883ADENOSINEHOSPIRA INC2014-03-24ANDA203883_001, ANDA203883_002
18NDA019937ADENOCARDASTELLAS PHARMA US INC1989-10-30NDA019937_002Adenosine Prefilled Syringe
19NDA020059ADENOSCANASTELLAS PHARMA US INC1995-05-18p5731296, SELECTIVE VASODILATION BY CONTINUOUS ADENOSINE INFUSIONNDA020059_001, NDA020059_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076404_001RXADENOSINE (3MG/ML)INJECTIONFalseAP2004-06-16ADENOSINE
2ANDA076500_001RXADENOSINE (3MG/ML)INJECTIONFalseAP2004-06-16ADENOSINE
3ANDA076501_001discontinuedADENOSINE (3MG/ML)INJECTIONFalse2004-06-16ADENOSINE
4ANDA076564_001discontinuedADENOSINE (3MG/ML)INJECTIONFalse2004-06-16ADENOSINE
5ANDA077133_001RXADENOSINE (3MG/ML)INJECTIONFalseAP2005-04-27ADENOSINE
6ANDA077283_001RXADENOSINE (3MG/ML)INJECTIONFalseAP2007-06-14ADENOSINE
7ANDA077425_001RXADENOSINE (60MG/20ML)SOLUTIONFalseAP2013-08-29ADENOSINE
8ANDA077425_002RXADENOSINE (90MG/30ML)SOLUTIONFalseAP2013-08-29ADENOSINE
9ANDA078076_001RXADENOSINE (3MG/ML)INJECTIONFalseAP2008-10-31ADENOSINE
10ANDA078640_001RXADENOSINE (3MG/ML)INJECTIONFalseAP2014-03-21ADENOSINE
11ANDA078676_001discontinuedADENOSINE (3MG/ML)INJECTIONFalse2008-07-31ADENOSINE
12ANDA078686_001RXADENOSINE (3MG/ML)INJECTIONFalseAP2009-05-13ADENOSINE
13ANDA090010_001RXADENOSINE (3MG/ML)INJECTIONFalseAP2009-04-28ADENOSINE
14ANDA090212_001RXADENOSINE (60MG/20ML)SOLUTIONFalseAP2014-03-28ADENOSINE
15ANDA090212_002RXADENOSINE (90MG/30ML)SOLUTIONFalseAP2014-03-28ADENOSINE
16ANDA090220_001discontinuedADENOSINE (3MG/ML)INJECTIONFalse2009-07-20ADENOSINE
17ANDA090450_001RXADENOSINE (60MG/20ML)SOLUTIONFalseAP2014-10-02ADENOSINE
18ANDA090450_002RXADENOSINE (90MG/30ML)SOLUTIONFalseAP2014-10-02ADENOSINE
19ANDA202313_001RXADENOSINE (60MG/20ML)SOLUTIONFalseAP2014-09-15ADENOSINE
20ANDA202313_002RXADENOSINE (90MG/30ML)SOLUTIONFalseAP2014-09-15ADENOSINE
21ANDA203883_001RXADENOSINE (60MG/20ML)SOLUTIONFalseAP2014-03-24ADENOSINE
22ANDA203883_002RXADENOSINE (90MG/30ML)SOLUTIONFalseAP2014-03-24ADENOSINE
23NDA019937_002RXADENOSINE (3MG/ML)INJECTIONTrueAP1989-10-30ADENOCARD
24NDA020059_001RXADENOSINE (60MG/20ML)SOLUTIONTrueAP1995-05-18ADENOSCAN
25NDA020059_002RXADENOSINE (90MG/30ML)SOLUTIONTrueAP1995-05-18ADENOSCAN

patent(s)

#idexpiration dateapplication(s)
1p5731296 (view patent)2015-03-24NDA020059

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1094fbe9b-8833-4eb1-a471-7518e7c23774 (view SPL)These highlights do not include all the information needed to use Adenosine Injection, USP safely and effectively. See full prescribing information for Adenosine Injection, USP. Adenosine Injection, USP, for intravenous use Initial U.S. Approval: 1995prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-07-162231550259
21828794c-fb0f-4170-a308-225a21b55f4c (view SPL)These highlights do not include all the information needed to use adenosine injection USP safely and effectively. See full prescribing information for adenosine injection USP. ADENOSINE injection USP, for intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-06-105007038776, 007038777
31ac3b6d9-7e57-4f27-8f78-436a6a55a9be (view SPL)Adenosine 90 mg/30mL in 0.9% Sodium Chloride 30 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-02-051525330236
421783911-37de-4797-b37d-bdf90030d112 (view SPL)ADENOSINE INJECTION, USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-10-031521250668
5356dac0f-258b-48a4-b7de-528ba2d241c8 (view SPL)ADENOSINE INJECTION USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-141548685551
63c04c033-72e5-469e-83ec-0182cad8be6e (view SPL)ADENOSINE INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-212551541279
75581a60e-8e5a-47de-9fb7-31c4fb05ac91 (view SPL)ADENOSINE INJECTION, USPFor Rapid Bolus Intravenous UseprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-161521250668
87ba23241-7d1e-4758-9f8d-5dac87ffb97f (view SPL)ADENOSINE INJECTION, USPFor Rapid Bolus Intravenous UseprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-241521250668
97fd858aa-f4ef-427b-a91c-c860cd27da9d (view SPL)These highlights do not include all the information needed to use ADENOSINE INJECTION, USP safely and effectively. See full prescribing information for ADENOSINE INJECTION, USP.ADENOSINE INJECTION, USP for intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionHospira, Inc.2015-07-162004091932
108b9c18db-9b4b-4465-b70c-d2db65c9da10 (view SPL)Adenosine Injection, USP(For Intravenous Infusion Only)prescriptionHuman PrescriptionSagent Pharmaceuticals2014-03-138250210307
118d14be75-5d52-4ff3-9124-6c2f06efef0f (view SPL)ADENOSCAN(adenosine injection)FOR INTRAVENOUS INFUSION ONLYprescriptionHuman PrescriptionRemedyrepack Inc.2013-10-311493490758
1291af0499-0efa-45e6-a5f8-2a0c491d1d18 (view SPL)ADENOSCAN(adenosine injection)FOR INTRAVENOUS INFUSION ONLYprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101521250758
13a4c5760e-049a-42df-adb2-5f47c3fc89a5 (view SPL)Adenosine 60 mg/20mL in 0.9% Sodium Chloride 20 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-02-182525330236
14a68d1eff-5cbb-4a6e-98e7-0fb6590ce2a0 (view SPL)ADENOSINE INJECTION, USPprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-10-184174780542
15a707f1be-12cc-411f-a965-fab1b2f29b8e (view SPL)Adenosine Injection, USPFOR RAPID BOLUS IV USEprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-03-261525840301
16b2bb0b15-283b-48c6-9401-3280ee21ef7f (view SPL)These highlights do not include all the information needed to use Adenosine Injection, USP safely and effectively. See full prescribing information for Adenosine Injection, USP. Adenosine Injection, USP for intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-242250210307
17b7013909-4624-4fb9-b2ef-2ca0d1f793cb (view SPL)Adenosine Injection USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2014-05-231521250948
18b827e3f8-dd63-4e54-90f4-0eded943de9f (view SPL)Adenosine Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2011-12-091006416113
19cba928b6-605a-4ca8-b6dc-cf478e9ad4f4 (view SPL)ADENOSCAN(adenosine injection)FOR INTRAVENOUS INFUSION ONLYprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-271493490758
20d2a51f9f-d51c-4540-955e-109581f77526 (view SPL)ADENOSINE INJECTION, USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-03-171521250668
21df9bed83-6c82-4294-9442-5e7464c3aab1 (view SPL)These highlights do not include all the information needed to use Adenosine Injection, USP safely and effectively. See full prescribing information for Adenosine Injection, USP. Adenosine Injection, USP, for intravenous use Initial U.S. Approval: 1995prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-08-283231550258
22e49090c7-8968-405f-85d4-17a0ec5bfc58 (view SPL)These highlights do not include all the information needed to use ADENOSCAN safely and effectively. See full prescribing information for ADENOSCAN. ADENOSCAN (adenosine) injection, for intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionFujisawa Healthcare, Inc.2014-08-318004690871
23e660f71c-35ed-438e-8505-4538f5e925a2 (view SPL)Adenosine Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-02-082633230651
24ee89d63b-123d-4995-b7cc-822c5bee16aa (view SPL)ADENOSINE INJECTION, USPFor Rapid Bolus Intravenous UseRx onlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-08-193525840026
25f2f1b4c5-1cfe-4b67-95b4-e1a0efc87777 (view SPL)These highlights do not include all the information needed to use Adenosine Injection, USP safely and effectively. See full prescribing information for Adenosine Injection, USP.Adenosine Injection, USP For intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-09-154174780544

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