Lorazepam Cartridge

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2011-05-26)
Oldest Current Product
2011-04-25
License(s)
ANDA
RxNORM
CARTRIDGE\LORAZEPAM
FDAOB
INJECTION\INJECTION\LORAZEPAM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\LORAZEPAM
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\LORAZEPAM

product(s) by strength(s)

1 ml lorazepam 2 mg/ml cartridge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091985ANDAHospira, Inc.2011-04-25, 2011-05-26LORAZEPAMINTRAMUSCULARINJECTION, SOLUTIONANDA07424320140b19-846b-425f-b191-670e17809945, a9f7d22e-43fc-46c8-b2a9-a00b0d25d4ac

1 ml lorazepam 4 mg/ml cartridge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091539ANDAHospira, Inc.2011-05-26LORAZEPAMINTRAMUSCULARINJECTION, SOLUTIONANDA07424320140b19-846b-425f-b191-670e17809945

application(s)

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

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)

#idtitlecategorytypelabelerlast updateversionproduct(s)
120140b19-846b-425f-b191-670e17809945 (view SPL)LORAZEPAMINJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2011-05-2611004091539, 004091985
2a9f7d22e-43fc-46c8-b2a9-a00b0d25d4ac (view SPL)LORAZEPAMINJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2011-05-1610004091985

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