Diltiazem Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cantrell Drug Company (2015-06-18)
Oldest Current Product
2006-12-21
License(s)
ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\DILTIAZEM
FDAOB
INJECTION\INJECTION\DILTIAZEM HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\DILTIAZEM HYDROCHLORIDE
INTRAVENOUS\INJECTION\DILTIAZEM HYDROCHLORIDE
INTRAVENOUS\POWDER, FOR SOLUTION\DILTIAZEM HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\DILTIAZEM
INTRAVENOUS\INJECTION\DILTIAZEM
INTRAVENOUS\POWDER, FOR SOLUTION\DILTIAZEM

product(s) by strength(s)

diltiazem hydrochloride 0.83 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330198UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2013-10-22DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION7fc9bee3-9e04-4b3e-a49b-3151d6623a3b

diltiazem hydrochloride 1 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330103UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2011-09-30DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION193375bf-bbd2-4a59-b051-ceebef53d9d5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004094350ANDAHospira, Inc.2011-10-20DILTIAZEM HYDROCHLORIDEINTRAVENOUSPOWDER, FOR SOLUTIONANDA075853875d1ed5-74b7-4494-ccad-96d2eec23c5a

diltiazem hydrochloride 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091171ANDAHospira, Inc.2012-04-10DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA074941bba03666-ff4f-4bf6-fa92-78e1ec2d9073
2006416013ANDAWest-Ward Pharmaceuticals Corp.2008-12-17DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078538453b73bd-c52d-4d72-a0b3-47588e723e0b
3006416014ANDAWest-Ward Pharmaceuticals Corp.2008-12-17DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078538453b73bd-c52d-4d72-a0b3-47588e723e0b
4006416015ANDAWest-Ward Pharmaceuticals Corp.2008-12-17DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078538453b73bd-c52d-4d72-a0b3-47588e723e0b
5174780817ANDAAkorn2013-11-12DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTIONANDA075086f5ea3383-5da4-4219-9802-3737a2eaeef4
6174780837ANDAAkorn2013-03-22DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTIONANDA07508681c5cf23-a6f8-454a-9575-d01edf49ed34
7174780937ANDAAkorn2006-12-21DILTIAZEM HYDROCHLORIDEINTRAVENOUSINJECTIONANDA0750865e36488b-8f2d-4dc9-b803-af1829e6fdd0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074617DILTIAZEM HYDROCHLORIDEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1996-02-28ANDA074617_001
2ANDA074894DILTIAZEM HYDROCHLORIDETEVA PHARMACEUTICALS USA1997-08-26ANDA074894_001, ANDA074894_002
3ANDA074941DILTIAZEM HYDROCHLORIDEHOSPIRA INC1998-04-15ANDA074941_001
4ANDA075004DILTIAZEM HYDROCHLORIDETrueHOSPIRA INC2000-02-16ANDA075004_001
5ANDA075086DILTIAZEM HYDROCHLORIDEAKORN INC1998-04-09ANDA075086_001
6ANDA075106DILTIAZEM HYDROCHLORIDETrueHOSPIRA INC1999-04-29ANDA075106_001
7ANDA075375DILTIAZEM HYDROCHLORIDETrueMYLAN LABORATORIES LTD1999-09-30ANDA075375_001
8ANDA075749DILTIAZEM HYDROCHLORIDEINTERNATIONAL MEDICATION SYSTEMS LTD2001-11-21ANDA075749_001
9ANDA075853DILTIAZEM HYDROCHLORIDEHOSPIRA INC2002-12-17ANDA075853_001
10ANDA078538DILTIAZEM HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2008-12-17ANDA078538_001
11ANDA202651DILTIAZEM HYDROCHLORIDEHIKMA FARMACEUTICA PORTUGAL SA2012-08-09ANDA202651_001
12NDA020027CARDIZEMTrueBIOVAIL LABORATORIES INTERNATIONAL SRL1991-10-24NDA020027_001, NDA020027_003
13NDA020792CARDIZEMTrueBIOVAIL LABORATORIES INC1997-09-05NDA020792_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074617_001RXDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONTrueAP1996-02-28DILTIAZEM HYDROCHLORIDE
2ANDA074894_001discontinuedDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalse1997-08-26DILTIAZEM HYDROCHLORIDE
3ANDA074894_002RXDILTIAZEM HYDROCHLORIDE (10MG/ML)INJECTIONTrue2002-04-19DILTIAZEM HYDROCHLORIDE
4ANDA074941_001RXDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP1998-04-15DILTIAZEM HYDROCHLORIDE
5ANDA075004_001discontinuedDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalse2000-02-16DILTIAZEM HYDROCHLORIDE
6ANDA075086_001RXDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP1998-04-09DILTIAZEM HYDROCHLORIDE
7ANDA075106_001discontinuedDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalse1999-04-29DILTIAZEM HYDROCHLORIDE
8ANDA075375_001discontinuedDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalse1999-09-30DILTIAZEM HYDROCHLORIDE
9ANDA075749_001RXDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP2001-11-21DILTIAZEM HYDROCHLORIDE
10ANDA075853_001RXDILTIAZEM HYDROCHLORIDE (100MG/VIAL)INJECTIONTrue2002-12-17DILTIAZEM HYDROCHLORIDE
11ANDA078538_001RXDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP2008-12-17DILTIAZEM HYDROCHLORIDE
12ANDA202651_001RXDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalseAP2012-08-09DILTIAZEM HYDROCHLORIDE
13NDA020027_001discontinuedDILTIAZEM HYDROCHLORIDE (5MG/ML)INJECTIONFalse1991-10-24CARDIZEM
14NDA020027_003discontinuedDILTIAZEM HYDROCHLORIDE (25MG/VIAL)INJECTIONFalse1995-08-18CARDIZEM
15NDA020792_001discontinuedDILTIAZEM HYDROCHLORIDE (100MG/VIAL)INJECTIONFalse1997-09-05CARDIZEM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1193375bf-bbd2-4a59-b051-ceebef53d9d5 (view SPL)Diltiazem HCl 125 mg in 5% Dextrose 100 mL Bag 125 mLprescriptionHuman PrescriptionCantrell Drug Company2015-06-187525330103
2453b73bd-c52d-4d72-a0b3-47588e723e0b (view SPL)Diltiazem Hydrochloride InjectionRx OnlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2011-10-121006416013, 006416014, 006416015
35e36488b-8f2d-4dc9-b803-af1829e6fdd0 (view SPL)Diltiazem Hydrochloride Injection,0.5% (5 mg/mL)prescriptionHuman PrescriptionAkornANALYSIS, MANUFACTURE, REPACK2011-08-011174780937
47fc9bee3-9e04-4b3e-a49b-3151d6623a3b (view SPL)Diltiazem HCl 250 mg in 5% Dextrose 300 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-01-122525330198
581c5cf23-a6f8-454a-9575-d01edf49ed34 (view SPL)Diltiazem Hydrochloride Injection,0.5% (5 mg/mL)prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-03-201174780837
6875d1ed5-74b7-4494-ccad-96d2eec23c5a (view SPL)Diltiazem Hydrochloride for InjectionprescriptionHuman PrescriptionHospira, Inc.2011-10-2010004094350
7bba03666-ff4f-4bf6-fa92-78e1ec2d9073 (view SPL)DILTIAZEM HYDROCHLORIDEINJECTIONprescriptionHuman PrescriptionHospira, Inc.2012-04-1010004091171
8f5ea3383-5da4-4219-9802-3737a2eaeef4 (view SPL)Diltiazem Hydrochloride Injection,0.5% (5 mg/mL)prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-11-111174780817

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