Labetalol Cartridge

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-10-19)
Oldest Current Product
1999-11-29
License(s)
ANDA
RxNORM
CARTRIDGE\LABETALOL
FDAOB
INJECTION\INJECTION\LABETALOL HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\LABETALOL HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\LABETALOL

product(s) by strength(s)

4 ml labetalol hydrochloride 5 mg/ml cartridge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092339ANDAHospira, Inc.1999-11-29LABETALOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA075239d3579d45-a964-40fe-e3a2-a3a997c8b7b9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544747ANDACardinal Health1999-11-29LABETALOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION004092339ANDA0752391b96ddc9-d0c3-488a-a113-66491fd3d899

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA075239LABETALOL HYDROCHLORIDEHOSPIRA INC1999-11-29ANDA075239_001Labetalol Injectable Solution
2ANDA075240LABETALOL HYDROCHLORIDEHOSPIRA INC1999-11-29ANDA075240_001Labetalol Injectable Solution
3ANDA075242LABETALOL HYDROCHLORIDETrueHOSPIRA INC1999-09-30ANDA075242_001Labetalol Injectable Solution
4ANDA075303LABETALOL HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL1999-05-28ANDA075303_001Labetalol Injectable Solution
5ANDA075355LABETALOL HYDROCHLORIDETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1999-11-29ANDA075355_001Labetalol Injectable Solution
6ANDA075431LABETALOL HYDROCHLORIDEAKORN INC1999-11-29ANDA075431_001Labetalol Injectable Solution
7ANDA075524LABETALOL HYDROCHLORIDEAKORN INC1999-11-29ANDA075524_001Labetalol Injectable Solution
8ANDA076051LABETALOL HYDROCHLORIDETrueCLARIS PHARMASERVICES2002-07-05ANDA076051_001Labetalol Injectable Solution
9ANDA079134LABETALOL HYDROCLORIDESAGENT STRIDES LLC2010-02-03ANDA079134_001Labetalol Injectable Solution
10ANDA090699LABETALOL HYDROCHLORIDEGLAND PHARMA LTD2012-04-03ANDA090699_001Labetalol Injectable Solution
11NDA018686NORMODYNETrueSCHERING CORP SUB SCHERING PLOUGH CORP1984-08-01NDA018686_001Labetalol Injectable Solution
12NDA019425TRANDATETruePROMETHEUS LABORATORIES INC1985-12-31NDA019425_001Labetalol Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075239_001RXLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONTrueAP1999-11-29LABETALOL HYDROCHLORIDE
2ANDA075240_001RXLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONTrueAP1999-11-29LABETALOL HYDROCHLORIDE
3ANDA075242_001discontinuedLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalse1999-09-30LABETALOL HYDROCHLORIDE
4ANDA075303_001RXLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP1999-05-28LABETALOL HYDROCHLORIDE
5ANDA075355_001discontinuedLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalse1999-11-29LABETALOL HYDROCHLORIDE
6ANDA075431_001RXLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP1999-11-29LABETALOL HYDROCHLORIDE
7ANDA075524_001RXLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP1999-11-29LABETALOL HYDROCHLORIDE
8ANDA076051_001discontinuedLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalse2002-07-05LABETALOL HYDROCHLORIDE
9ANDA079134_001RXLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP2010-02-03LABETALOL HYDROCLORIDE
10ANDA090699_001RXLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP2012-04-03LABETALOL HYDROCHLORIDE
11NDA018686_001discontinuedLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalse1984-08-01NORMODYNE
12NDA019425_001discontinuedLABETALOL HYDROCHLORIDE (5MG/ML)INJECTIONFalse1985-12-31TRANDATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11b96ddc9-d0c3-488a-a113-66491fd3d899 (view SPL)Labetalol HydrochlorideprescriptionHuman PrescriptionCardinal HealthREPACK2014-07-081551544747
2d3579d45-a964-40fe-e3a2-a3a997c8b7b9 (view SPL)Labetalol HydrochlorideprescriptionHuman PrescriptionHospira, Inc.2015-10-1913004092339

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