Midazolam Cartridge

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2012-07-23)
Oldest Current Product
2002-06-13
License(s)
ANDA
RxNORM
CARTRIDGE\MIDAZOLAM
FDAOB
INJECTION\INJECTION\MIDAZOLAM HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\MIDAZOLAM HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\MIDAZOLAM

product(s) by strength(s)

2 ml midazolam 1 mg/ml cartridge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092306ANDAHospira, Inc.2002-06-13MIDAZOLAM HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0758566add8355-2ad8-422e-1289-027aecbc3b62, 79d3ba03-8032-43bd-af8e-022e54c38611, c3736d08-3fe5-48f7-a1b9-1284514283b5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551546997ANDACardinal Health2002-06-13MIDAZOLAM HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004092306ANDA075856506c80c2-5054-4ccd-b389-d0b159a9216c

1 ml midazolam 5 mg/ml cartridge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092307ANDAHospira, Inc.2002-06-13MIDAZOLAM HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0758566add8355-2ad8-422e-1289-027aecbc3b62, c3736d08-3fe5-48f7-a1b9-1284514283b5

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA075154MIDAZOLAM HYDROCHLORIDEFRESENIUS KABI USA LLC2000-06-20ANDA075154_001, ANDA075154_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
2ANDA075243MIDAZOLAM HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2000-06-20ANDA075243_001, ANDA075243_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
3ANDA075247MIDAZOLAM HYDROCHLORIDEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2000-06-23ANDA075247_001, ANDA075247_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
4ANDA075249MIDAZOLAM HYDROCHLORIDETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2000-06-23ANDA075249_001Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
5ANDA075263MIDAZOLAM HYDROCHLORIDETrueIGI LABORATORIES INC2000-06-26ANDA075263_001Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
6ANDA075293MIDAZOLAM HYDROCHLORIDEHOSPIRA INC2000-06-20ANDA075293_001, ANDA075293_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
7ANDA075324MIDAZOLAM HYDROCHLORIDEHIKMA MAPLE LTD2000-06-20ANDA075324_001, ANDA075324_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
8ANDA075396MIDAZOLAM HYDROCHLORIDETrueHOSPIRA INC2000-06-20ANDA075396_001, ANDA075396_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
9ANDA075409MIDAZOLAM HYDROCHLORIDETrueHOSPIRA INC2000-06-20ANDA075409_001, ANDA075409_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
10ANDA075421MIDAZOLAM HYDROCHLORIDEBEDFORD LABORATORIES2000-06-20ANDA075421_001, ANDA075421_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
11ANDA075455MIDAZOLAM HYDROCHLORIDETrueBEN VENUE LABORATORIES INC2000-06-20ANDA075455_001Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
12ANDA075481MIDAZOLAM HYDROCHLORIDEAKORN INC2000-06-30ANDA075481_001Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
13ANDA075484MIDAZOLAM HYDROCHLORIDETrueHOSPIRA INC2000-06-20ANDA075484_001Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
14ANDA075494MIDAZOLAM HYDROCHLORIDEAKORN INC2000-06-30ANDA075494_001, ANDA075494_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
15ANDA075620MIDAZOLAM HYDROCHLORIDETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB2000-11-01ANDA075620_001, ANDA075620_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
16ANDA075637MIDAZOLAM HYDROCHLORIDETrueCLARIS PHARMASERVICES2000-10-31ANDA075637_001, ANDA075637_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
17ANDA075641MIDAZOLAM HYDROCHLORIDETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB2000-10-19ANDA075641_001Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
18ANDA075856MIDAZOLAM HYDROCHLORIDEHOSPIRA INC2002-06-13ANDA075856_001, ANDA075856_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
19ANDA075857MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEHOSPIRA INC2002-07-22ANDA075857_001, ANDA075857_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
20ANDA076020MIDAZOLAM HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEMS LTD2004-07-16ANDA076020_001, ANDA076020_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
21ANDA076144MIDAZOLAM HYDROCHLORIDETrueINTERNATIONAL MEDICATED SYSTEMS LTD2005-01-26ANDA076144_001, ANDA076144_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
22ANDA078141MIDAZOLAM HYDROCHLORIDETrueWOCKHARDT LTD2008-05-30ANDA078141_001, ANDA078141_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
23ANDA078511MIDAZOLAM HYDROCHLORIDETrueWOCKHARDT LTD2008-11-10ANDA078511_001, ANDA078511_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
24ANDA090315MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREESAGENT STRIDES LLC2010-11-29ANDA090315_001, ANDA090315_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
25ANDA090316MIDOZALAM HYDROCHLORIDESAGENT STRIDES LLC2011-05-04ANDA090316_001, ANDA090316_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
26ANDA090696MIDAZOLAM HYDROCHLORIDEGLAND PHARMA LTD2012-02-29ANDA090696_001Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
27ANDA090850MIDAZOLAM HYDROCHLORIDEGLAND PHARMA LTD2012-01-25ANDA090850_001Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
28ANDA203460MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEBD RX INC2014-08-22ANDA203460_001, ANDA203460_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection
29NDA018654VERSEDTrueHLR TECHNOLOGY1985-12-20NDA018654_001, NDA018654_002Midazolam Injectable Solution
Midazolam Prefilled Syringe
Midazolam Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075154_001RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2000-06-20MIDAZOLAM HYDROCHLORIDE
2ANDA075154_002RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2000-06-20MIDAZOLAM HYDROCHLORIDE
3ANDA075243_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2000-06-20MIDAZOLAM HYDROCHLORIDE
4ANDA075243_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2000-06-20MIDAZOLAM HYDROCHLORIDE
5ANDA075247_001RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2000-06-23MIDAZOLAM HYDROCHLORIDE
6ANDA075247_002RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2000-06-23MIDAZOLAM HYDROCHLORIDE
7ANDA075249_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-06-23MIDAZOLAM HYDROCHLORIDE
8ANDA075263_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-06-26MIDAZOLAM HYDROCHLORIDE
9ANDA075293_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONTrueAP2000-06-20MIDAZOLAM HYDROCHLORIDE
10ANDA075293_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONTrueAP2000-06-20MIDAZOLAM HYDROCHLORIDE
11ANDA075324_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2000-06-20MIDAZOLAM HYDROCHLORIDE
12ANDA075324_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2000-06-20MIDAZOLAM HYDROCHLORIDE
13ANDA075396_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2000-06-20MIDAZOLAM HYDROCHLORIDE
14ANDA075396_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-06-20MIDAZOLAM HYDROCHLORIDE
15ANDA075409_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-06-20MIDAZOLAM HYDROCHLORIDE
16ANDA075409_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2000-06-20MIDAZOLAM HYDROCHLORIDE
17ANDA075421_001RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2000-06-20MIDAZOLAM HYDROCHLORIDE
18ANDA075421_002RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2000-06-20MIDAZOLAM HYDROCHLORIDE
19ANDA075455_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-06-20MIDAZOLAM HYDROCHLORIDE
20ANDA075481_001RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2000-06-30MIDAZOLAM HYDROCHLORIDE
21ANDA075484_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-06-20MIDAZOLAM HYDROCHLORIDE
22ANDA075494_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2000-06-30MIDAZOLAM HYDROCHLORIDE
23ANDA075494_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2000-06-30MIDAZOLAM HYDROCHLORIDE
24ANDA075620_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2000-11-01MIDAZOLAM HYDROCHLORIDE
25ANDA075620_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-11-01MIDAZOLAM HYDROCHLORIDE
26ANDA075637_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2000-10-31MIDAZOLAM HYDROCHLORIDE
27ANDA075637_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-10-31MIDAZOLAM HYDROCHLORIDE
28ANDA075641_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2000-10-19MIDAZOLAM HYDROCHLORIDE
29ANDA075856_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2002-06-13MIDAZOLAM HYDROCHLORIDE
30ANDA075856_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2002-06-13MIDAZOLAM HYDROCHLORIDE
31ANDA075857_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONTrueAP2002-07-22MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
32ANDA075857_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONTrueAP2002-07-22MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
33ANDA076020_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2004-07-16MIDAZOLAM HYDROCHLORIDE
34ANDA076020_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2004-07-16MIDAZOLAM HYDROCHLORIDE
35ANDA076144_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2005-01-26MIDAZOLAM HYDROCHLORIDE
36ANDA076144_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2005-01-26MIDAZOLAM HYDROCHLORIDE
37ANDA078141_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2008-05-30MIDAZOLAM HYDROCHLORIDE
38ANDA078141_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2008-05-30MIDAZOLAM HYDROCHLORIDE
39ANDA078511_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2008-11-10MIDAZOLAM HYDROCHLORIDE
40ANDA078511_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse2008-11-10MIDAZOLAM HYDROCHLORIDE
41ANDA090315_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2010-11-29MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
42ANDA090315_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2010-11-29MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
43ANDA090316_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2011-05-04MIDOZALAM HYDROCHLORIDE
44ANDA090316_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2011-05-04MIDOZALAM HYDROCHLORIDE
45ANDA090696_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2012-02-29MIDAZOLAM HYDROCHLORIDE
46ANDA090850_001RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2012-01-25MIDAZOLAM HYDROCHLORIDE
47ANDA203460_001RXMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2014-08-22MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
48ANDA203460_002RXMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2014-08-22MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
49NDA018654_001discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1985-12-20VERSED
50NDA018654_002discontinuedMIDAZOLAM HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse1987-05-26VERSED

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1506c80c2-5054-4ccd-b389-d0b159a9216c (view SPL)Midazolam Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-08-201551546997
26add8355-2ad8-422e-1289-027aecbc3b62 (view SPL)Midazolam Injection, USPprescriptionHuman PrescriptionHospira, Inc.2012-07-2311004092306, 004092307
379d3ba03-8032-43bd-af8e-022e54c38611 (view SPL)MidazolamprescriptionHuman PrescriptionHospira, Inc.2014-02-2414004092306
4c3736d08-3fe5-48f7-a1b9-1284514283b5 (view SPL)MIDAZOLAM Injection, USPprescriptionHuman PrescriptionHospira, Inc.2012-07-1911004092306, 004092307

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