Labetalol Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-09-11)
Oldest Current Product
1999-11-29
License(s)
ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\LABETALOL
FDAOB
INJECTION\INJECTION\LABETALOL HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\LABETALOL HYDROCHLORIDE
INTRAVENOUS\INJECTION\LABETALOL HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\LABETALOL
INTRAVENOUS\INJECTION\LABETALOL

product(s) by strength(s)

labetalol hydrochloride 5 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330034UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2012-02-23LABETALOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONf0a9df5b-45b5-4be5-aeb6-76d0c27a7799

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092267ANDAHospira, Inc.1999-11-29, 2013-07-22LABETALOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA075240abfc6b75-1ed5-41f1-0484-4597488237bc, f6e529bf-fe4d-4091-a3c2-774245b5f0a1
2174780420ANDAAkorn2004-09-01LABETALOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA07543117bb21ce-9bb1-4603-b168-abea7fc85d17
3250210300ANDASagent Pharmaceuticals2010-02-17LABETALOL HYDROCHLORIDEINTRAVENOUSINJECTIONANDA079134d8e0af49-8c2a-4ada-804f-17ce2abad15b
4674570280ANDAMylan Institutional Llc2012-06-29LABETALOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA090699c567200b-2caa-441f-946c-33f7be3e7d6a
5680830111ANDAGland Pharma Limited2012-04-19LABETALOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA09069948caf986-3126-48e1-afcd-16d65c9cfe00

application(s)

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

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)
117bb21ce-9bb1-4603-b168-abea7fc85d17 (view SPL)Labetalol Hydrochloride Injection, USPprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK, STERILIZE2011-12-134174780420
248caf986-3126-48e1-afcd-16d65c9cfe00 (view SPL)Rx onlyprescriptionHuman PrescriptionGland Pharma LimitedANALYSIS, MANUFACTURE2012-04-193680830111
3abfc6b75-1ed5-41f1-0484-4597488237bc (view SPL)Labetalol HydrochlorideprescriptionHuman PrescriptionHospira, Inc.2015-09-1113004092267
4c567200b-2caa-441f-946c-33f7be3e7d6a (view SPL)Labetalol Hydrochloride Injection, USPprescriptionHuman PrescriptionMylan Institutional Llc2012-03-014674570280
5d8e0af49-8c2a-4ada-804f-17ce2abad15b (view SPL)Labetalol Hydrochloride Injection, USP(For IV Use Only)prescriptionHuman PrescriptionSagent Pharmaceuticals2012-09-279250210300
6f0a9df5b-45b5-4be5-aeb6-76d0c27a7799 (view SPL)Labetalol HCl 5 mg/mL 4 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-05-025525330034
7f6e529bf-fe4d-4091-a3c2-774245b5f0a1 (view SPL)Labetalol HydrochlorideprescriptionHuman PrescriptionHospira, Inc.2015-09-112004092267

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