Lorazepam Injectable Solution

Brand(s)
Ativan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceuticals Corp. (2011-12-06)
Oldest Current Product
1980-07-25
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\LORAZEPAM
FDAOB
INJECTION\INJECTION\LORAZEPAM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\LORAZEPAM
INTRAMUSCULAR\INJECTION\LORAZEPAM
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\LORAZEPAM
INTRAMUSCULAR\INJECTION\LORAZEPAM

product(s) by strength(s)

lorazepam 2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416000AtivanNDAWest-Ward Pharmaceuticals Corp.1980-07-25LORAZEPAMINTRAMUSCULARINJECTIONNDA0181405fc0e987-61c9-40c4-b0d5-fcea07c8733e
2006416050NDAWest-Ward Pharmaceuticals Corp.1980-07-25LORAZEPAMINTRAMUSCULARINJECTIONNDA0181404084fa74-9fd2-45ef-9d56-27bfa31d4e46

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096780ANDAHospira, Inc.1994-05-27LORAZEPAMINTRAMUSCULARINJECTION, SOLUTIONANDA074282608a0345-fc9c-4170-4f8d-96dbdd7e566a
2763298261ANDAInternational Medication Systems, Limited2012-12-01LORAZEPAMINTRAMUSCULARINJECTIONANDA0761507dda070d-7809-46c4-8592-eb4e4c509707

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1617860316NDARemedyrepack Inc.2015-11-14LORAZEPAMINTRAMUSCULARINJECTION006416044NDA018140759f5e83-99a6-4891-9070-d2cc18ad73ab

lorazepam 4 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416002AtivanNDAWest-Ward Pharmaceuticals Corp.1980-07-25LORAZEPAMINTRAMUSCULARINJECTIONNDA0181405fc0e987-61c9-40c4-b0d5-fcea07c8733e
2006416047NDAWest-Ward Pharmaceuticals Corp.1980-07-25LORAZEPAMINTRAMUSCULARINJECTIONNDA018140e9b54e42-04cf-4c62-90e1-36f7b31a4e81

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096781ANDAHospira, Inc.1994-05-27LORAZEPAMINTRAMUSCULARINJECTION, SOLUTIONANDA074282608a0345-fc9c-4170-4f8d-96dbdd7e566a

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA074243LORAZEPAMHOSPIRA INC1994-04-12ANDA074243_001, ANDA074243_002Lorazepam Injection
Lorazepam Cartridge
2ANDA074276LORAZEPAMTrueWATSON LABORATORIES INC1994-04-15ANDA074276_001, ANDA074276_002Lorazepam Injection
Lorazepam Cartridge
3ANDA074280LORAZEPAMTrueHOSPIRA INC1994-05-27ANDA074280_001, ANDA074280_002Lorazepam Injection
Lorazepam Cartridge
4ANDA074282LORAZEPAMHOSPIRA INC1994-05-27ANDA074282_001, ANDA074282_002Lorazepam Injection
Lorazepam Cartridge
5ANDA074300LORAZEPAMTrueHOSPIRA INC1994-04-12ANDA074300_001, ANDA074300_003Lorazepam Injection
Lorazepam Cartridge
6ANDA074496LORAZEPAMTrueHIKMA MAPLE LTD1998-09-28ANDA074496_001, ANDA074496_002Lorazepam Injection
Lorazepam Cartridge
7ANDA074535LORAZEPAMTrueWATSON LABORATORIES INC1996-09-12ANDA074535_001, ANDA074535_002Lorazepam Injection
Lorazepam Cartridge
8ANDA074551LORAZEPAMTrueWATSON LABORATORIES INC1996-09-12ANDA074551_001, ANDA074551_002, ANDA074551_003Lorazepam Injection
Lorazepam Cartridge
9ANDA074793LORAZEPAMTrueDAVA PHARMACEUTICALS INC2000-03-16ANDA074793_001, ANDA074793_002Lorazepam Injection
Lorazepam Cartridge
10ANDA074974LORAZEPAMTrueAKORN INC1998-07-23ANDA074974_001Lorazepam Injection
Lorazepam Cartridge
11ANDA075025LORAZEPAMAKORN INC1998-07-23ANDA075025_001Lorazepam Injection
Lorazepam Cartridge
12ANDA076150LORAZEPAMINTERNATIONAL MEDICATION SYSTEMS LTD2004-11-15ANDA076150_001Lorazepam Injection
Lorazepam Cartridge
13ANDA077074LORAZEPAM PRESERVATIVE FREEBEDFORD LABORATORIES2005-07-13ANDA077074_001, ANDA077074_002Lorazepam Injection
Lorazepam Cartridge
14ANDA077076LORAZEPAMTrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2005-07-13ANDA077076_001, ANDA077076_002Lorazepam Injection
Lorazepam Cartridge
15NDA018140ATIVANEUROHEALTH INTERNATIONAL SARLNDA018140_001, NDA018140_002Lorazepam Injection
Lorazepam Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074243_001RXLORAZEPAM (2MG/ML)INJECTIONFalseAP1994-04-12LORAZEPAM
2ANDA074243_002RXLORAZEPAM (4MG/ML)INJECTIONFalseAP1994-04-12LORAZEPAM
3ANDA074276_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse1994-04-15LORAZEPAM
4ANDA074276_002discontinuedLORAZEPAM (4MG/ML)INJECTIONFalse1994-04-15LORAZEPAM
5ANDA074280_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse1994-05-27LORAZEPAM
6ANDA074280_002discontinuedLORAZEPAM (4MG/ML)INJECTIONFalse1994-05-27LORAZEPAM
7ANDA074282_001RXLORAZEPAM (2MG/ML)INJECTIONFalseAP1994-05-27LORAZEPAM
8ANDA074282_002RXLORAZEPAM (4MG/ML)INJECTIONFalseAP1994-05-27LORAZEPAM
9ANDA074300_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse1994-04-12LORAZEPAM
10ANDA074300_003discontinuedLORAZEPAM (4MG/ML)INJECTIONFalse1997-03-19LORAZEPAM
11ANDA074496_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse1998-09-28LORAZEPAM
12ANDA074496_002discontinuedLORAZEPAM (4MG/ML)INJECTIONFalse1998-09-28LORAZEPAM
13ANDA074535_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse1996-09-12LORAZEPAM
14ANDA074535_002discontinuedLORAZEPAM (4MG/ML)INJECTIONFalse1996-09-12LORAZEPAM
15ANDA074551_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse1996-09-12LORAZEPAM
16ANDA074551_002discontinuedLORAZEPAM (4MG/ML)INJECTIONFalse1996-09-12LORAZEPAM
17ANDA074551_003discontinuedLORAZEPAM (1MG/0.5ML)INJECTIONFalse1996-09-12LORAZEPAM
18ANDA074793_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse2000-03-16LORAZEPAM
19ANDA074793_002discontinuedLORAZEPAM (4MG/ML)INJECTIONFalse2000-03-16LORAZEPAM
20ANDA074974_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse1998-07-23LORAZEPAM
21ANDA075025_001RXLORAZEPAM (2MG/ML)INJECTIONFalseAP1998-07-23LORAZEPAM
22ANDA076150_001RXLORAZEPAM (2MG/ML)INJECTIONFalseAP2004-11-15LORAZEPAM
23ANDA077074_001RXLORAZEPAM (2MG/ML)INJECTIONFalseAP2005-07-13LORAZEPAM PRESERVATIVE FREE
24ANDA077074_002RXLORAZEPAM (4MG/ML)INJECTIONFalseAP2005-07-13LORAZEPAM PRESERVATIVE FREE
25ANDA077076_001discontinuedLORAZEPAM (2MG/ML)INJECTIONFalse2005-07-13LORAZEPAM
26ANDA077076_002discontinuedLORAZEPAM (4MG/ML)INJECTIONFalse2005-07-13LORAZEPAM
27NDA018140_001RXLORAZEPAM (2MG/ML)INJECTIONTrueAPATIVAN
28NDA018140_002RXLORAZEPAM (4MG/ML)INJECTIONTrueAPATIVAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
14084fa74-9fd2-45ef-9d56-27bfa31d4e46 (view SPL)Lorazepam Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-12-061006416050, 006416048, 006416049, 006416051Lorazepam Injection
25fc0e987-61c9-40c4-b0d5-fcea07c8733e (view SPL)ATIVANInjection (lorazepam injection, USP)prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2011-11-162006416000, 006416002, 006416001, 006416003Lorazepam Injection
3608a0345-fc9c-4170-4f8d-96dbdd7e566a (view SPL)LORAZEPAMInjection, USPprescriptionHuman PrescriptionHospira, Inc.2012-07-1011004096780, 004096781, 004096778, 004096779Lorazepam Injection
4759f5e83-99a6-4891-9070-d2cc18ad73ab (view SPL)Lorazepam Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-11-141617860316
57dda070d-7809-46c4-8592-eb4e4c509707 (view SPL)prescriptionHuman PrescriptionInternational Medication Systems, Limitedanalysis, label, manufacture2015-05-132763298261
6e9b54e42-04cf-4c62-90e1-36f7b31a4e81 (view SPL)Lorazepam Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2011-11-152006416047, 006416044, 006416045, 006416046Lorazepam Injection

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