Amiodarone Injection

Brand(s)
Nexterone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-03-13)
Oldest Current Product
2002-10-14
License(s)
NDA, ANDA
RxNORM
INJECTION\AMIODARONE
FDAOB
INJECTION\INJECTION\AMIODARONE HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\AMIODARONE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\AMIODARONE HYDROCHLORIDE
INTRAVENOUS\INJECTION\AMIODARONE HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\AMIODARONE
INTRAVENOUS\INJECTION, SOLUTION\AMIODARONE
INTRAVENOUS\INJECTION\AMIODARONE

product(s) by strength(s)

100 ml amiodarone hydrochloride 1.5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1430660150NexteroneNDABaxter Healthcare Corporation2010-11-16AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA022325e9108958-b8d7-4fba-87c3-9a32990de551

200 ml amiodarone hydrochloride 1.8 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1430660360NexteroneNDABaxter Healthcare Corporation2010-11-16AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA022325e9108958-b8d7-4fba-87c3-9a32990de551

amiodarone hydrochloride 50 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230616ANDAApp Pharmaceuticals, Llc2003-01-28AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA075761d8d04647-8e25-4127-8ecf-360ce1991c2f
2674570153ANDAMylan Institutional Llc2002-10-14AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA076217fcc8658c-761a-443f-8c32-1499d86028ec

3 ml amiodarone hydrochloride 50 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439875ANDAWest-Ward Pharmaceutical Corp2008-02-25AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA07723451772745-9ea9-42cd-97e6-7266f41ae3ca
2004091934ANDAHospira, Inc.2013-11-25AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA20388404efa7dc-7be0-495c-85a4-3d9d6ed5840a
3004094348ANDAHospira, Inc.2002-10-18AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA075955cdd50dc7-f712-4248-b0e3-ba247cf08cee
4556480739ANDAWockhardt Limited2008-10-30AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTIONANDA077610b0eb6c22-7553-4e3f-a06d-20a186ced99a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840153ANDAGeneral Injecatables & Vaccines, Inc2012-06-06AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION674570153ANDA076217b7e2af06-1fe4-4b45-ae5d-bc6279ca47f3
2525840348ANDAGeneral Injecatables & Vaccines, Inc2010-03-01AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE004094348ANDA075955f446e1b0-2c46-4763-8eb0-b3a6be956f69
3525840875ANDAGeneral Injecatables & Vaccines, Inc2014-09-02AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION001439875ANDA077234c5d11e6d-d78f-40f0-87bd-6909088141d0
4548685722ANDAPhysicians Total Care, Inc.2006-12-11AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION674570153ANDA076217304d0be4-0c13-4dbb-8ffb-b2e7caa7fb1e
5617860394ANDARemedyrepack Inc.2015-08-19AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION001439875ANDA0772342ae89f66-73cc-414d-a173-b23d9607ccb9

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA075761AMIODARONE HYDROCHLORIDEFRESENIUS KABI USA LLC2002-10-15ANDA075761_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
2ANDA075955AMIODARONE HYDROCHLORIDEHOSPIRA INC2002-10-18ANDA075955_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
3ANDA076018AMIODARONE HYDROCHLORIDETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2002-10-15ANDA076018_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
4ANDA076088AMIODARONE HYDROCHLORIDETrueBEN VENUE LABORATORIES INC2002-10-15ANDA076088_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
5ANDA076108AMIODARONE HYDROCHLORIDETrueHOSPIRA INC2002-10-15ANDA076108_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
6ANDA076163AMIODARONE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA2003-09-05ANDA076163_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
7ANDA076217AMIODARONE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2002-10-15ANDA076217_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
8ANDA076232AMIODARONE HYDROCHLORIDEAKORN INC2006-07-05ANDA076232_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
9ANDA076299AMIODARONE HYDROCHLORIDETrueBEDFORD LABORATORIES2002-10-24ANDA076299_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
10ANDA076394AMIODARONE HYDROCHLORIDETruePAR STERILE PRODUCTS LLC2003-04-25ANDA076394_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
11ANDA077161AMIODARONE HYDROCHLORIDEGLAND PHARMA LTD2005-04-20ANDA077161_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
12ANDA077234AMIODARONE HYDROCHLORIDEHIKMA FARMACEUTICA (PORTUGAL) SA2008-02-25ANDA077234_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
13ANDA077610AMIODARONE HYDROCHLORIDEWOCKHARDT LTD2008-10-30ANDA077610_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
14ANDA077834AMIODARONE HYDROCHLORIDEWOCKHARDT LTD2008-10-30ANDA077834_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
15ANDA203884AMIODARONE HYDROCHLORIDEHOSPIRA INC2013-11-25ANDA203884_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
16ANDA203885AMIODARONE HYDROCHLORIDEHOSPIRA INC2013-11-25ANDA203885_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
17NDA020377CORDARONETrueWYETH PHARMACEUTICALS INC1995-08-03NDA020377_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
18NDA021594AMIODARONE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEMS LTD2004-02-04NDA021594_001Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
19NDA022325NEXTERONEBAXTER HEALTHCARE CORP2008-12-24p7635773, SUBSTANCE
p6869939, SUBSTANCE
NDA022325_001, NDA022325_002, NDA022325_003Amiodarone Prefilled Syringe
Amiodarone Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075761_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAP2002-10-15AMIODARONE HYDROCHLORIDE
2ANDA075955_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAP2002-10-18AMIODARONE HYDROCHLORIDE
3ANDA076018_001discontinuedAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalse2002-10-15AMIODARONE HYDROCHLORIDE
4ANDA076088_001discontinuedAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalse2002-10-15AMIODARONE HYDROCHLORIDE
5ANDA076108_001discontinuedAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalse2002-10-15AMIODARONE HYDROCHLORIDE
6ANDA076163_001discontinuedAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalse2003-09-05AMIODARONE HYDROCHLORIDE
7ANDA076217_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAP2002-10-15AMIODARONE HYDROCHLORIDE
8ANDA076232_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAP2006-07-05AMIODARONE HYDROCHLORIDE
9ANDA076299_001discontinuedAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalse2002-10-24AMIODARONE HYDROCHLORIDE
10ANDA076394_001discontinuedAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalse2003-04-25AMIODARONE HYDROCHLORIDE
11ANDA077161_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAP2005-04-20AMIODARONE HYDROCHLORIDE
12ANDA077234_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2008-02-25AMIODARONE HYDROCHLORIDE
13ANDA077610_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2008-10-30AMIODARONE HYDROCHLORIDE
14ANDA077834_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2008-10-30AMIODARONE HYDROCHLORIDE
15ANDA203884_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2013-11-25AMIODARONE HYDROCHLORIDE
16ANDA203885_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2013-11-25AMIODARONE HYDROCHLORIDE
17NDA020377_001discontinuedAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1995-08-03CORDARONE
18NDA021594_001discontinuedAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalse2004-02-04AMIODARONE HYDROCHLORIDE
19NDA022325_001RXAMIODARONE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAP2008-12-24NEXTERONE
20NDA022325_002RXAMIODARONE HYDROCHLORIDE (150MG/100ML)INJECTIONTrue2010-11-16NEXTERONE
21NDA022325_003RXAMIODARONE HYDROCHLORIDE (360MG/200ML)INJECTIONTrue2010-11-16NEXTERONE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6869939 (view patent)2022-05-04NDA022325Amiodarone Prefilled Syringe
Amiodarone Injectable Solution
2p7635773 (view patent)2029-03-13NDA022325Amiodarone Prefilled Syringe
Amiodarone Injectable Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
104efa7dc-7be0-495c-85a4-3d9d6ed5840a (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985prescriptionHuman PrescriptionHospira, Inc.2013-12-021004091934, 004091933Amiodarone Injectable Solution
22ae89f66-73cc-414d-a173-b23d9607ccb9 (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985prescriptionHuman PrescriptionRemedyrepack Inc.2015-08-191617860394
3304d0be4-0c13-4dbb-8ffb-b2e7caa7fb1e (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-03-081548685722
451772745-9ea9-42cd-97e6-7266f41ae3ca (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2012-12-044001439875
5b0eb6c22-7553-4e3f-a06d-20a186ced99a (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl Injection for intravenous useInitial U.S. Approval: 1985prescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2012-11-061556480739
6b7e2af06-1fe4-4b45-ae5d-bc6279ca47f3 (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCL injection for intravenous use Initial U.S. Approval: 1985prescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-12-192525840153
7c5d11e6d-d78f-40f0-87bd-6909088141d0 (view SPL)AMIODARONE HYDROCHLORIDE HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use amiodarone safely and effectively.See full prescribing information for amiodarone injection.Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1995prescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-09-021525840875
8cdd50dc7-f712-4248-b0e3-ba247cf08cee (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection.Amiodarone HCl injection for intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionHospira, Inc.2013-03-0111004094348
9d8d04647-8e25-4127-8ecf-360ce1991c2f (view SPL)Amiodarone Hydrochloride InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-01-251633230616
10e9108958-b8d7-4fba-87c3-9a32990de551 (view SPL)These highlights do not include all the information needed to use NEXTERONE safely and effectively. See full prescribing information for NEXTERONE. NEXTERONE (amiodarone HCl) Premixed Injection for intravenous useInitial U.S. Approval: 1985prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-03-136430660150, 430660360
11f446e1b0-2c46-4763-8eb0-b3a6be956f69 (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection.Amiodarone HCL injection for intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-09-064525840348
12fcc8658c-761a-443f-8c32-1499d86028ec (view SPL)These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 1985prescriptionHuman PrescriptionMylan Institutional Llc2012-08-318674570153

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