Rocuronium Injectable Solution

Brand(s)
Zemuron
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
X-Gen Pharmaceuticals, Inc. (2015-07-06)
Oldest Current Product
1994-03-17
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\ROCURONIUM
FDAOB
INJECTION\INJECTION\ROCURONIUM BROMIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ROCURONIUM BROMIDE
INTRAVENOUS\INJECTION\ROCURONIUM BROMIDE
INTRAVENOUS\SOLUTION\ROCURONIUM BROMIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ROCURONIUM
INTRAVENOUS\INJECTION\ROCURONIUM
INTRAVENOUS\SOLUTION\ROCURONIUM

product(s) by strength(s)

rocuronium bromide 10 mg/ml injectable solution

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1250210662Sagent PharmaceuticalsROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONc8ca72af-cfc1-4c9f-9754-4f98abcffc3f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004099558ANDAHospira, Inc.2008-11-26, 2008-12-15ROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONANDA078519309aeb1b-8022-4df7-8194-ae6529e3395c, cccd40ca-5f08-4acb-8548-3cad558388bb
2007032394ANDATeva Parenteral Medicines, Inc2008-12-01ROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONANDA078717117ec4c4-07d6-42b1-a537-43fbc93d901d
3007032395ANDATeva Parenteral Medicines, Inc2008-12-01ROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONANDA078717117ec4c4-07d6-42b1-a537-43fbc93d901d
4007813220ANDASandoz Inc2008-12-05ROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONANDA079195cb28d869-6510-4402-9462-f6bb25fa0fa8
5398224200ANDAX-Gen Pharmaceuticals, Inc.2012-12-01ROCURONIUM BROMIDEINTRAVENOUSSOLUTIONANDA091115b73f192c-2912-4ec3-9b4f-05a58d9b35ba
6633230426ANDAApp Pharmaceuticals, Llc2009-12-13ROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONANDA078651f1933332-1ae0-4dc1-be4c-694849e6c9f9
7652930426ANDAThe Medicines Company2009-12-13ROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONANDA0786516ec8c417-6613-45e0-bc86-293a8b1ee83f
8652930427ANDAThe Medicines Company2009-12-13ROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONANDA0786516ec8c417-6613-45e0-bc86-293a8b1ee83f
9674570228ANDAMylan Institutional Llc2012-02-06ROCURONIUM BROMIDEINTRAVENOUSINJECTIONANDA079199f58803b0-f173-4997-b2f8-0f415b94dacf
10674570573ANDAMylan Institutional Llc2014-09-29ROCURONIUM BROMIDEINTRAVENOUSINJECTIONANDA079199f58803b0-f173-4997-b2f8-0f415b94dacf
11674570574ANDAMylan Institutional Llc2014-09-29ROCURONIUM BROMIDEINTRAVENOUSINJECTIONANDA079199f58803b0-f173-4997-b2f8-0f415b94dacf

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000520450ZemuronNDAOrganon Usa Inc.1994-03-17ROCURONIUM BROMIDEINTRAVENOUSINJECTION, SOLUTIONNDA020214b7d5e4f6-8798-4385-97c7-cf22c8fcc66f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1617860222ANDARemedyrepack Inc.2015-03-11ROCURONIUM BROMIDEINTRAVENOUSINJECTION674570228ANDA079199e92f2faf-9ed2-4b30-98e4-78a4be6827ce

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA078519ROCURONIUM BROMIDEHOSPIRA INC2008-11-26ANDA078519_001, ANDA078519_002
2ANDA078651ROCURONIUM BROMIDEFRESENIUS KABI USA LLC2008-12-29ANDA078651_001, ANDA078651_002
3ANDA078717ROCURONIUM BROMIDETEVA PHARMACEUTICALS USA2008-11-26ANDA078717_001, ANDA078717_002
4ANDA079195ROCURONIUM BROMIDESANDOZ CANADA INC2008-12-05ANDA079195_001, ANDA079195_002
5ANDA079199ROCURONIUM BROMIDEMYLAN INSTITUTIONAL LLC2008-11-26ANDA079199_001, ANDA079199_002
6ANDA091115ROCURONIUM BROMIDETAMARANG SA2012-08-27ANDA091115_001, ANDA091115_002
7ANDA091458ROCURONIUM BROMIDESAGENT PHARMACEUTICALS INC2010-07-28ANDA091458_001, ANDA091458_002
8NDA020214ZEMURONTrueORGANON USA INC1994-03-17NDA020214_001, NDA020214_002, NDA020214_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA078519_001RXROCURONIUM BROMIDE (50MG/5ML)INJECTIONFalseAP2008-11-26ROCURONIUM BROMIDE
2ANDA078519_002RXROCURONIUM BROMIDE (100MG/10ML)INJECTIONFalseAP2008-11-26ROCURONIUM BROMIDE
3ANDA078651_001RXROCURONIUM BROMIDE (50MG/5ML)INJECTIONFalseAP2008-12-29ROCURONIUM BROMIDE
4ANDA078651_002RXROCURONIUM BROMIDE (100MG/10ML)INJECTIONFalseAP2008-12-29ROCURONIUM BROMIDE
5ANDA078717_001RXROCURONIUM BROMIDE (50MG/5ML)INJECTIONFalseAP2008-11-26ROCURONIUM BROMIDE
6ANDA078717_002RXROCURONIUM BROMIDE (100MG/10ML)INJECTIONFalseAP2008-11-26ROCURONIUM BROMIDE
7ANDA079195_001RXROCURONIUM BROMIDE (50MG/5ML)INJECTIONTrueAP2008-12-05ROCURONIUM BROMIDE
8ANDA079195_002RXROCURONIUM BROMIDE (100MG/10ML)INJECTIONTrueAP2008-12-05ROCURONIUM BROMIDE
9ANDA079199_001RXROCURONIUM BROMIDE (50MG/5ML)INJECTIONFalseAP2008-11-26ROCURONIUM BROMIDE
10ANDA079199_002RXROCURONIUM BROMIDE (100MG/10ML)INJECTIONFalseAP2008-11-26ROCURONIUM BROMIDE
11ANDA091115_001RXROCURONIUM BROMIDE (50MG/5ML)INJECTIONFalseAP2012-08-27ROCURONIUM BROMIDE
12ANDA091115_002RXROCURONIUM BROMIDE (100MG/10ML)INJECTIONFalseAP2012-08-27ROCURONIUM BROMIDE
13ANDA091458_001RXROCURONIUM BROMIDE (50MG/5ML)INJECTIONFalseAP2010-07-28ROCURONIUM BROMIDE
14ANDA091458_002RXROCURONIUM BROMIDE (100MG/10ML)INJECTIONFalseAP2010-07-28ROCURONIUM BROMIDE
15NDA020214_001discontinuedROCURONIUM BROMIDE (50MG/5ML)INJECTIONFalse1994-03-17ZEMURON
16NDA020214_002discontinuedROCURONIUM BROMIDE (10MG/ML)INJECTIONFalse1994-03-17ZEMURON
17NDA020214_003discontinuedROCURONIUM BROMIDE (100MG/10ML)INJECTIONFalse1994-03-17ZEMURON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1117ec4c4-07d6-42b1-a537-43fbc93d901d (view SPL)These highlights do not include all the information needed to use rocuronium bromide safely and effectively. See full prescribing information for rocuronium bromide. ROCURONIUM BROMIDE injection solution for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-05-287007032394, 007032395
2309aeb1b-8022-4df7-8194-ae6529e3395c (view SPL)These highlights do not include all the information needed to use ROCURONIUM BROMIDE INJECTION safely and effectively. See full prescribing information for ROCURONIUM BROMIDE INJECTION. ROCURONIUM BROMIDE INJECTION SOLUTION for Intravenous Use Initial U.S. Approval: 1994prescriptionHuman PrescriptionHospira, Inc.2015-01-2115004099558
36ec8c417-6613-45e0-bc86-293a8b1ee83f (view SPL)These highlights do not include all the information needed to use Rocuronium Bromide Injection safely and effectively. See full prescribing information for Rocuronium Bromide Injection. Rocuronium Bromide Injection solution for intravenous useInitial U.S. Approval: 1994prescriptionHuman PrescriptionThe Medicines CompanyMANUFACTURE2012-07-311652930426, 652930427
4b73f192c-2912-4ec3-9b4f-05a58d9b35ba (view SPL)These highlights do not include all the information needed to use ROCURONIUM BROMIDE INJECTION safely and effectively. See full prescribing information for ROCURONIUM BROMIDE INJECTION. ROCURONIUM Bromide Injection for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-07-066398224200
5b7d5e4f6-8798-4385-97c7-cf22c8fcc66f (view SPL)These highlights do not include all the information needed to use ZEMURON safely and effectively. See full prescribing information for ZEMURON. ZEMURON (rocuronium bromide) injection solution for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionOrganon Usa Inc.API MANUFACTURE, MANUFACTURE, PACK2015-01-1510000520450
6c8ca72af-cfc1-4c9f-9754-4f98abcffc3f (view SPL)These highlights do not include all the information needed to use rocuronium bromide injection safely and effectively. See full prescribing information for rocuronium bromide injection.Rocuronium bromide injection for intravenous useInitial U.S. Approval: 1994prescriptionHuman PrescriptionSagent Pharmaceuticals2015-02-109250210662
7cb28d869-6510-4402-9462-f6bb25fa0fa8 (view SPL)These highlights do not include all the information needed to use ROCURONIUM BROMIDE safely and effectively. See full prescribing information for ROCURONIUM BROMIDE.ROCURONIUM BROMIDE injection solution for intravenous useInitial U.S. Approval: 1994prescriptionHuman PrescriptionSandoz Inc2015-01-1514007813220
8cccd40ca-5f08-4acb-8548-3cad558388bb (view SPL)These highlights do not include all the information needed to use ROCURONIUM BROMIDE INJECTION safely and effectively. See full prescribing information for ROCURONIUM BROMIDE INJECTION. ROCURONIUM BROMIDE INJECTION SOLUTION for Intravenous Use Initial U.S. Approval: 1994prescriptionHuman PrescriptionHospira, Inc.2015-01-212004099558
9e92f2faf-9ed2-4b30-98e4-78a4be6827ce (view SPL)These highlights do not include all the information needed to use rocuronium bromide injection safely and effectively. See full prescribing information for rocuronium bromide injection.Rocuronium bromide injection solution for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionRemedyrepack Inc.2015-03-111617860222
10f1933332-1ae0-4dc1-be4c-694849e6c9f9 (view SPL)These highlights do not include all the information needed to use Rocuronium Bromide Injection safely and effectively. See full prescribing information for Rocuronium Bromide Injection. Rocuronium Bromide Injection solution for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-06-173633230426
11f58803b0-f173-4997-b2f8-0f415b94dacf (view SPL)These highlights do not include all the information needed to use rocuronium bromide injection safely and effectively. See full prescribing information for rocuronium bromide injection.ROCURONIUM bromide injection solution for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Institutional Llc2015-03-3111674570228, 674570573, 674570574

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