Digoxin Injectable Solution

Brand(s)
Lanoxin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Covis Pharmaceuticals, Inc. (2015-08-07)
Oldest Current Product
1975-10-24
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DIGOXIN
FDAOB
INJECTION\INJECTION\DIGOXIN\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\DIGOXIN
INTRAMUSCULAR\INJECTION\DIGOXIN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\DIGOXIN
INTRAMUSCULAR\INJECTION\DIGOXIN

product(s) by strength(s)

digoxin 0.1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870262LanoxinNDACovis Pharmaceuticals, Inc.2013-01-14DIGOXININTRAMUSCULARINJECTION, SOLUTIONNDA0093303e66b3d0-d36e-4795-b707-e27ecae5723d, 58678fd6-afe3-4a4c-a37f-356444194cd6

digoxin 0.25 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870260LanoxinNDACovis Pharmaceuticals, Inc.2013-02-15DIGOXININTRAMUSCULARINJECTION, SOLUTIONNDA0093303e66b3d0-d36e-4795-b707-e27ecae5723d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006411410ANDAWest-Ward Pharmaceuticals Corp.1975-10-24DIGOXININTRAMUSCULARINJECTIONANDA0833913933b07f-5857-4a80-b502-e3214bdf9330
2006416184ANDAWest-Ward Pharmaceuticals Corp.1975-10-24DIGOXININTRAMUSCULARINJECTIONANDA0833919b9a4b3c-5f08-475a-a74d-0c7ebba40644
3007813059ANDASandoz Inc2003-08-21DIGOXININTRAMUSCULARINJECTION, SOLUTIONANDA04048158f45aba-ff6f-43cc-bb88-be40a9f7beda

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840410ANDAGeneral Injecatables & Vaccines, Inc2010-07-01DIGOXININTRAMUSCULARINJECTION006411410ANDA083391017021a4-25a4-4914-aab3-c21daf97ea50
2551541113LanoxinNDACardinal Health1985-10-01DIGOXININTRAMUSCULARINJECTION, SOLUTION001730260NDA009330bf0bcd81-38b8-482f-8865-61d8fb9a5c59
3551545106ANDACardinal Health2011-06-28DIGOXININTRAMUSCULARINJECTION006411410ANDA0833916aba2b38-5de0-4813-9775-39d87613893d

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040092DIGOXIN PEDIATRICTrueHOSPIRA INC1996-04-25ANDA040092_001
2ANDA040093DIGOXINTrueHOSPIRA INC1996-05-16ANDA040093_001
3ANDA040206DIGOXINTrueHOSPIRA INC1998-08-28ANDA040206_001
4ANDA040481DIGOXINSANDOZ CANADA INC2003-08-21ANDA040481_001
5ANDA083217DIGOXINTrueABRAXIS PHARMACEUTICAL PRODUCTSANDA083217_001
6ANDA083391DIGOXINEUROHEALTH INTERNATIONAL SARLANDA083391_001
7ANDA084386DIGOXINTrueWYETH AYERST LABORATORIESANDA084386_001
8NDA009330LANOXINCOVIS INJECTABLES SARLNDA009330_002, NDA009330_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040092_001discontinuedDIGOXIN (0.1MG/ML)INJECTIONFalse1996-04-25DIGOXIN PEDIATRIC
2ANDA040093_001discontinuedDIGOXIN (0.25MG/ML)INJECTIONFalse1996-05-16DIGOXIN
3ANDA040206_001discontinuedDIGOXIN (0.25MG/ML)INJECTIONFalse1998-08-28DIGOXIN
4ANDA040481_001RXDIGOXIN (0.25MG/ML)INJECTIONFalseAP2003-08-21DIGOXIN
5ANDA083217_001discontinuedDIGOXIN (0.25MG/ML)INJECTIONFalseDIGOXIN
6ANDA083391_001RXDIGOXIN (0.25MG/ML)INJECTIONFalseAPDIGOXIN
7ANDA084386_001discontinuedDIGOXIN (0.25MG/ML)INJECTIONFalseDIGOXIN
8NDA009330_002RXDIGOXIN (0.25MG/ML)INJECTIONTrueAPLANOXIN
9NDA009330_004RXDIGOXIN (0.1MG/ML)INJECTIONTrueLANOXIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1017021a4-25a4-4914-aab3-c21daf97ea50 (view SPL)Digoxin, Inj 250 mcg/mL Injection, USP 2 mL Single Dose AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-05-074525840410
23933b07f-5857-4a80-b502-e3214bdf9330 (view SPL)These highlights do not include all the information needed to usedigoxin safely and effectively. See full prescribing information for digoxin. Digoxin Injection, for intravenous or intramuscular useInitial U.S. Approval: 1954prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK2015-09-1816006411410
33e66b3d0-d36e-4795-b707-e27ecae5723d (view SPL)These highlights do not include all the information needed to use LANOXIN safely and effectively. See full prescribing information for LANOXIN. LANOXIN (digoxin) injection, for intravenous or intramuscular useInitial U.S. Approval: 1954prescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2015-08-074249870260, 249870262
458678fd6-afe3-4a4c-a37f-356444194cd6 (view SPL)LANOXIN (digoxin) Injection Pediatric100mcg (0.1mg) in 1mLprescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2013-01-142249870262
558f45aba-ff6f-43cc-bb88-be40a9f7beda (view SPL)These highlights do not include all the information needed to use DIGOXIN INJECTION USP safely and effectively. See full prescribing information for DIGOXIN INJECTION USP. Digoxin Injection USP, for intravenous or intramuscular useInitial U.S. Approval: 1954prescriptionHuman PrescriptionSandoz Inc2015-08-0416007813059
66aba2b38-5de0-4813-9775-39d87613893d (view SPL)These highlights do not include all the information needed to usedigoxin safely and effectively. See full prescribing information for digoxin. Digoxin Injection, for intravenous or intramuscular useInitial U.S. Approval: 1954prescriptionHuman PrescriptionCardinal HealthREPACK2014-09-096551545106
79b9a4b3c-5f08-475a-a74d-0c7ebba40644 (view SPL)NOVAPLUSThese highlights do not include all the information needed to usedigoxin safely and effectively. See full prescribing information for digoxin.Digoxin Injection, for intravenous or intramuscular useInitial U.S. Approval: 1954prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2015-10-081006416184
8bf0bcd81-38b8-482f-8865-61d8fb9a5c59 (view SPL)LANOXIN (digoxin)Injection500mcg (0.5mg) in 2mL (250mcg [0.25mg] per mL)prescriptionHuman PrescriptionCardinal HealthREPACK2012-04-092551541113

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