Lorazepam Injection

Brand(s)
Ativan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceuticals Corp. (2011-12-06)
Oldest Current Product
1980-07-01
License(s)
NDA, ANDA
RxNORM
INJECTION\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)

1 ml lorazepam 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416001AtivanNDAWest-Ward Pharmaceuticals Corp.1980-07-25LORAZEPAMINTRAMUSCULARINJECTIONNDA0181405fc0e987-61c9-40c4-b0d5-fcea07c8733e
2006416048NDAWest-Ward Pharmaceuticals Corp.1980-07-25LORAZEPAMINTRAMUSCULARINJECTIONNDA0181404084fa74-9fd2-45ef-9d56-27bfa31d4e46

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096778ANDAHospira, Inc.1994-05-27LORAZEPAMINTRAMUSCULARINJECTION, SOLUTIONANDA074282608a0345-fc9c-4170-4f8d-96dbdd7e566a
2174780040ANDAAkorn1980-07-01LORAZEPAMINTRAMUSCULARINJECTIONANDA075025b5b17cde-a94c-4105-871c-54e7d2bd47e8

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683566ANDAPhysicians Total Care, Inc.2007-01-10LORAZEPAMINTRAMUSCULARINJECTION, SOLUTION004091985ANDA0743009f495605-0959-442c-8636-9c2d2f93bdff

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1647256044NDATya Pharmaceuticals1980-07-25LORAZEPAMINTRAMUSCULARINJECTION006416044NDA018140a3e2fbad-d850-4bac-9a45-dc1e75e37cab

1 ml lorazepam 4 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416003AtivanNDAWest-Ward Pharmaceuticals Corp.1980-07-25LORAZEPAMINTRAMUSCULARINJECTIONNDA0181405fc0e987-61c9-40c4-b0d5-fcea07c8733e
2006416045NDAWest-Ward Pharmaceuticals Corp.1980-07-25LORAZEPAMINTRAMUSCULARINJECTIONNDA018140e9b54e42-04cf-4c62-90e1-36f7b31a4e81

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096779ANDAHospira, Inc.1994-05-27LORAZEPAMINTRAMUSCULARINJECTION, SOLUTIONANDA074282608a0345-fc9c-4170-4f8d-96dbdd7e566a

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA074243LORAZEPAMHOSPIRA INC1994-04-12ANDA074243_001, ANDA074243_002Lorazepam Injectable Solution
Lorazepam Cartridge
2ANDA074276LORAZEPAMTrueWATSON LABORATORIES INC1994-04-15ANDA074276_001, ANDA074276_002Lorazepam Injectable Solution
Lorazepam Cartridge
3ANDA074280LORAZEPAMTrueHOSPIRA INC1994-05-27ANDA074280_001, ANDA074280_002Lorazepam Injectable Solution
Lorazepam Cartridge
4ANDA074282LORAZEPAMHOSPIRA INC1994-05-27ANDA074282_001, ANDA074282_002Lorazepam Injectable Solution
Lorazepam Cartridge
5ANDA074300LORAZEPAMTrueHOSPIRA INC1994-04-12ANDA074300_001, ANDA074300_003Lorazepam Injectable Solution
Lorazepam Cartridge
6ANDA074496LORAZEPAMTrueHIKMA MAPLE LTD1998-09-28ANDA074496_001, ANDA074496_002Lorazepam Injectable Solution
Lorazepam Cartridge
7ANDA074535LORAZEPAMTrueWATSON LABORATORIES INC1996-09-12ANDA074535_001, ANDA074535_002Lorazepam Injectable Solution
Lorazepam Cartridge
8ANDA074551LORAZEPAMTrueWATSON LABORATORIES INC1996-09-12ANDA074551_001, ANDA074551_002, ANDA074551_003Lorazepam Injectable Solution
Lorazepam Cartridge
9ANDA074793LORAZEPAMTrueDAVA PHARMACEUTICALS INC2000-03-16ANDA074793_001, ANDA074793_002Lorazepam Injectable Solution
Lorazepam Cartridge
10ANDA074974LORAZEPAMTrueAKORN INC1998-07-23ANDA074974_001Lorazepam Injectable Solution
Lorazepam Cartridge
11ANDA075025LORAZEPAMAKORN INC1998-07-23ANDA075025_001Lorazepam Injectable Solution
Lorazepam Cartridge
12ANDA076150LORAZEPAMINTERNATIONAL MEDICATION SYSTEMS LTD2004-11-15ANDA076150_001Lorazepam Injectable Solution
Lorazepam Cartridge
13ANDA077074LORAZEPAM PRESERVATIVE FREEBEDFORD LABORATORIES2005-07-13ANDA077074_001, ANDA077074_002Lorazepam Injectable Solution
Lorazepam Cartridge
14ANDA077076LORAZEPAMTrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2005-07-13ANDA077076_001, ANDA077076_002Lorazepam Injectable Solution
Lorazepam Cartridge
15NDA018140ATIVANEUROHEALTH INTERNATIONAL SARLNDA018140_001, NDA018140_002Lorazepam Injectable Solution
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, MANUFACTURE2011-12-061006416048, 006416049, 006416050, 006416051Lorazepam Injectable Solution
25fc0e987-61c9-40c4-b0d5-fcea07c8733e (view SPL)ATIVANInjection (lorazepam injection, USP)prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2011-11-162006416001, 006416003, 006416000, 006416002Lorazepam Injectable Solution
3608a0345-fc9c-4170-4f8d-96dbdd7e566a (view SPL)LORAZEPAMInjection, USPprescriptionHuman PrescriptionHospira, Inc.2012-07-1011004096778, 004096779, 004096780, 004096781Lorazepam Injectable Solution
49f495605-0959-442c-8636-9c2d2f93bdff (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-06-181548683566
5a3e2fbad-d850-4bac-9a45-dc1e75e37cab (view SPL)Lorazepam Injection, USPprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2011-11-152647256044
6b5b17cde-a94c-4105-871c-54e7d2bd47e8 (view SPL)LORAZEPAM INJECTION, USPprescriptionHuman PrescriptionAkornANALYSIS, MANUFACTURE, REPACK2014-11-042174780040
7e9b54e42-04cf-4c62-90e1-36f7b31a4e81 (view SPL)Lorazepam Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2011-11-152006416045, 006416044, 006416046, 006416047Lorazepam Injectable Solution

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