Flumazenil Injectable Solution

Brand(s)
Romazicon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Llc (2014-01-10)
Oldest Current Product
2004-10-12
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\FLUMAZENIL
FDAOB
INJECTION\INJECTION\FLUMAZENIL\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\FLUMAZENIL
INTRAVENOUS\INJECTION\FLUMAZENIL
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\FLUMAZENIL
INTRAVENOUS\INJECTION\FLUMAZENIL

product(s) by strength(s)

flumazenil 0.1 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690093ANDAPfizer Labs2011-05-10FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA078595a04d1c2b-8b05-48fd-877f-c7376dd57629
2000690105ANDAPfizer Labs2011-05-10FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA078595a04d1c2b-8b05-48fd-877f-c7376dd57629
3001439683ANDAWest-Ward Pharmaceutical Corp2009-03-23FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA078527436f5616-9626-4b6a-9deb-2986444179d0
4001439684ANDAWest-Ward Pharmaceutical Corp2009-03-23FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA078527436f5616-9626-4b6a-9deb-2986444179d0
5001439783ANDAWest-Ward Pharmaceutical Corp2007-01-01FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA078527442ed32b-b508-40cc-9915-ff05674566da
6001439784ANDAWest-Ward Pharmaceutical Corp2007-01-01FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA078527442ed32b-b508-40cc-9915-ff05674566da
7006416031ANDAWest-Ward Pharmaceuticals Corp.2004-10-12FLUMAZENILINTRAVENOUSINJECTIONANDA07678717f3ea88-b403-4ee3-840a-640a0b9682b7
8006416032ANDAWest-Ward Pharmaceuticals Corp.2004-10-12FLUMAZENILINTRAVENOUSINJECTIONANDA07678717f3ea88-b403-4ee3-840a-640a0b9682b7
9007813003ANDASandoz Inc2005-05-03FLUMAZENILINTRAVENOUSINJECTIONANDA077071cf39cdaf-8cb7-4dbb-8672-9cf8e91ac86c
10250210600ANDASagent Pharmaceuticals2012-09-15FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA090584a9742932-ff8c-454e-933f-195b51d94664
11633230424ANDAApp Pharmaceuticals, Llc2005-04-05FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA076955a72d9fc1-121c-455d-93a9-002378c9968f
12674570447ANDAMylan Institutional Llc2011-05-10FLUMAZENILINTRAVENOUSINJECTION, SOLUTIONANDA078595f5716b57-6e5c-4c89-9d4e-5be0bc86c5be

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840911RomaziconNDAGeneral Injecatables & Vaccines, Inc2010-09-01FLUMAZENILINTRAVENOUSINJECTION, SOLUTION000046911NDA02007399130b62-7ef7-4ef1-b717-de0798d39aba
2525840912RomaziconNDAGeneral Injecatables & Vaccines, Inc2010-08-01FLUMAZENILINTRAVENOUSINJECTION, SOLUTION000046912NDA02007369049fa6-7dc4-4ae7-99f4-06839af06498
3548685715ANDAPhysicians Total Care, Inc.2006-12-11FLUMAZENILINTRAVENOUSINJECTION00703208403ANDA07658993b8ae30-aafb-4808-879e-dffe5194fdf6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840022ANDAGeneral Injecatables & Vaccines, Inc2011-07-26FLUMAZENILINTRAVENOUSINJECTION, SOLUTION007813003ANDA077071864c8566-5597-46ab-8c08-4eaed660f068
2525840045ANDAGeneral Injecatables & Vaccines, Inc2013-03-13FLUMAZENILINTRAVENOUSINJECTION, SOLUTION000690093ANDA078595ce66aebd-0f76-4fb2-8d94-c1a23bfffa12
3525840092ANDAGeneral Injecatables & Vaccines, Inc2011-02-18FLUMAZENILINTRAVENOUSINJECTION553900092ANDA076256628efd34-8121-4f8d-8006-f8f659b5dd29
4525840093ANDAGeneral Injecatables & Vaccines, Inc2011-02-18FLUMAZENILINTRAVENOUSINJECTION553900093ANDA076256bf7d0367-df73-47d2-b4a0-66bbf5e119a2
5525840105ANDAGeneral Injecatables & Vaccines, Inc2013-03-13FLUMAZENILINTRAVENOUSINJECTION, SOLUTION000690105ANDA07859586aeed5c-249d-46db-a43e-8ca34e813029
6525840321ANDAGeneral Injecatables & Vaccines, Inc2010-03-01FLUMAZENILINTRAVENOUSINJECTION, SOLUTION100190321ANDA076787c9f59aa6-ab0b-47ef-bc98-189965936a27
7525840783ANDAGeneral Injecatables & Vaccines, Inc2014-09-16FLUMAZENILINTRAVENOUSINJECTION001439783ANDA078527b94647e1-7419-445e-9489-77e8eefe2e4c
8525840784ANDAGeneral Injecatables & Vaccines, Inc2014-07-10FLUMAZENILINTRAVENOUSINJECTION001439784ANDA0785276747db05-eb6e-4760-9269-9a6c82e41b3c
9551547474ANDACardinal Health2007-01-01FLUMAZENILINTRAVENOUSINJECTION, SOLUTION001439784ANDA078527e6237019-490f-4162-bfe0-6e2d08c0a1be

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076256FLUMAZENILBEDFORD LABORATORIES2004-10-12ANDA076256_001, ANDA076256_002
2ANDA076589FLUMAZENILTrueTEVA PHARMACEUTICALS USA2004-10-12ANDA076589_001, ANDA076589_002
3ANDA076755FLUMAZENILTrueCLARIS PHARMASERVICES2004-10-12ANDA076755_001, ANDA076755_002
4ANDA076787FLUMAZENILEUROHEALTH INTERNATIONAL SARL2004-10-12ANDA076787_001, ANDA076787_002
5ANDA076955FLUMAZENILFRESENIUS KABI USA LLC2004-10-12ANDA076955_001, ANDA076955_002
6ANDA077071FLUMAZENILSANDOZ CANADA INC2005-05-03ANDA077071_001, ANDA077071_002
7ANDA078527FLUMAZENILHIKMA FARMACEUTICA (PORTUGAL) SA2009-03-23ANDA078527_001, ANDA078527_002
8ANDA078595FLUMAZENILMYLAN LABORATORIES LTD2008-05-13ANDA078595_001, ANDA078595_002
9ANDA090584FLUMAZENILSAGENT PHARMACEUTICALS INC2012-08-28ANDA090584_001, ANDA090584_002
10NDA020073ROMAZICONTrueHOFFMANN LA ROCHE INC1991-12-20NDA020073_001, NDA020073_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076256_001RXFLUMAZENIL (1MG/10ML)INJECTIONFalseAP2004-10-12FLUMAZENIL
2ANDA076256_002RXFLUMAZENIL (0.5MG/5ML)INJECTIONFalseAP2004-10-12FLUMAZENIL
3ANDA076589_001discontinuedFLUMAZENIL (1MG/10ML)INJECTIONFalse2004-10-12FLUMAZENIL
4ANDA076589_002discontinuedFLUMAZENIL (0.5MG/5ML)INJECTIONFalse2004-10-12FLUMAZENIL
5ANDA076755_001discontinuedFLUMAZENIL (1MG/10ML)INJECTIONFalse2004-10-12FLUMAZENIL
6ANDA076755_002discontinuedFLUMAZENIL (0.5MG/5ML)INJECTIONFalse2004-10-12FLUMAZENIL
7ANDA076787_001RXFLUMAZENIL (1MG/10ML)INJECTIONFalseAP2004-10-12FLUMAZENIL
8ANDA076787_002RXFLUMAZENIL (0.5MG/5ML)INJECTIONFalseAP2004-10-12FLUMAZENIL
9ANDA076955_001RXFLUMAZENIL (1MG/10ML)INJECTIONFalseAP2004-10-12FLUMAZENIL
10ANDA076955_002RXFLUMAZENIL (0.5MG/5ML)INJECTIONFalseAP2004-10-12FLUMAZENIL
11ANDA077071_001RXFLUMAZENIL (0.5MG/5ML)INJECTIONFalseAP2005-05-03FLUMAZENIL
12ANDA077071_002RXFLUMAZENIL (1MG/10ML)INJECTIONFalseAP2005-05-03FLUMAZENIL
13ANDA078527_001RXFLUMAZENIL (0.5MG/5ML)INJECTIONFalseAP2009-03-23FLUMAZENIL
14ANDA078527_002RXFLUMAZENIL (1MG/10ML)INJECTIONFalseAP2009-03-23FLUMAZENIL
15ANDA078595_001RXFLUMAZENIL (0.5MG/5ML)INJECTIONFalseAP2008-05-13FLUMAZENIL
16ANDA078595_002RXFLUMAZENIL (1MG/10ML)INJECTIONTrueAP2008-05-13FLUMAZENIL
17ANDA090584_001RXFLUMAZENIL (0.5MG/5ML)INJECTIONFalseAP2012-08-28FLUMAZENIL
18ANDA090584_002RXFLUMAZENIL (1MG/10ML)INJECTIONFalseAP2012-08-28FLUMAZENIL
19NDA020073_001discontinuedFLUMAZENIL (1MG/10ML)INJECTIONFalse1991-12-20ROMAZICON
20NDA020073_002discontinuedFLUMAZENIL (0.5MG/5ML)INJECTIONFalse1991-12-20ROMAZICON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
117f3ea88-b403-4ee3-840a-640a0b9682b7 (view SPL)Flumazenil Injection, USP Rx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2011-09-281006416031, 006416032
2436f5616-9626-4b6a-9deb-2986444179d0 (view SPL)FLUMAZENIL INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2013-08-234001439683, 001439684
3442ed32b-b508-40cc-9915-ff05674566da (view SPL)FlumazenilprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2011-03-074001439783, 001439784
4628efd34-8121-4f8d-8006-f8f659b5dd29 (view SPL)Flumazenil 0.5mg/5mlprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-252525840092
56747db05-eb6e-4760-9269-9a6c82e41b3c (view SPL)FlumazenilprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-07-101525840784
669049fa6-7dc4-4ae7-99f4-06839af06498 (view SPL)Romazicon (Flumazenil) 1 mg/10 mL 0.1 mg/mL Injection 10 mL Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-261525840912
7864c8566-5597-46ab-8c08-4eaed660f068 (view SPL)Flumazenil InjectionprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-02-012525840022
886aeed5c-249d-46db-a43e-8ca34e813029 (view SPL)flumazenil injection, USPRx OnlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-03-131525840105
993b8ae30-aafb-4808-879e-dffe5194fdf6 (view SPL)Flumazenil InjectionprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-10-091548685715
1099130b62-7ef7-4ef1-b717-de0798d39aba (view SPL)Romazicon (Flumazenil) 0.5 mg/5 mL, 0.1 mg/mL Injection, USP 5 mL Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-09-021525840911
11a04d1c2b-8b05-48fd-877f-c7376dd57629 (view SPL)FLUMAZENIL INJECTION, USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2013-06-114000690093, 000690105
12a72d9fc1-121c-455d-93a9-002378c9968f (view SPL)Flumazenil Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-231633230424
13a9742932-ff8c-454e-933f-195b51d94664 (view SPL)Flumazenil Injection, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-267250210600
14b94647e1-7419-445e-9489-77e8eefe2e4c (view SPL)FLUMAZENILprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-09-151525840783
15bf7d0367-df73-47d2-b4a0-66bbf5e119a2 (view SPL)Flumazenil 0.1 mg/ml injection, USP 10ml Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-252525840093
16c9f59aa6-ab0b-47ef-bc98-189965936a27 (view SPL)Flumazenil 0.1 mg/mL Injection, USP 5mL Multi-Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-09-162525840321
17ce66aebd-0f76-4fb2-8d94-c1a23bfffa12 (view SPL)flumazenil injection, USPRx OnlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-03-081525840045
18cf39cdaf-8cb7-4dbb-8672-9cf8e91ac86c (view SPL)Flumazenil InjectionprescriptionHuman PrescriptionSandoz Inc2012-03-0711007813003
19e6237019-490f-4162-bfe0-6e2d08c0a1be (view SPL)FlumazenilprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-171551547474
20f5716b57-6e5c-4c89-9d4e-5be0bc86c5be (view SPL)Flumazenil Injection, USPRx onlyprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-01-101674570447

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