Amiodarone Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2013-12-02)
Oldest Current Product
2013-11-25
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\AMIODARONE
FDAOB
INJECTION\INJECTION\AMIODARONE HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\AMIODARONE HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\AMIODARONE

product(s) by strength(s)

amiodarone hydrochloride 50 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091933ANDAHospira, Inc.2013-11-25AMIODARONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA20388504efa7dc-7be0-495c-85a4-3d9d6ed5840a

application(s)

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

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 Injection
2p7635773 (view patent)2029-03-13NDA022325Amiodarone Prefilled Syringe
Amiodarone Injection

spl(s)

#idtitlecategorytypelabelerlast 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.2013-12-021004091933, 004091934Amiodarone Injection

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