Digoxin Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2015-07-31)
Oldest Current Product
2004-08-26
License(s)
NDA
RxNORM
ORAL SOLUTION\DIGOXIN
FDAOB
ORAL\ELIXIR\DIGOXIN
SPL Active
ORAL\SOLUTION\DIGOXIN
SPL Moiety
ORAL\SOLUTION\DIGOXIN

product(s) by strength(s)

digoxin 0.05 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540057NDARoxane Laboratories, Inc2004-08-26DIGOXINORALSOLUTIONNDA0216481b7e5c6e-e052-41b0-a4ce-05dfe62faaaf

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560057NDAAtlantic Biologicals Corps2004-08-26DIGOXINORALSOLUTION000540057NDA021648dcf907d9-0f0e-4ecc-a555-7e6dcc08c166
2680940752NDAPrecision Dose Inc.2012-05-04DIGOXINORALSOLUTION000540057NDA0216487b03a2d7-f17c-4954-85c9-fb78cfec7d76

application(s)

#idtitleapplicantapprovedapproved drug
1NDA021648DIGOXINROXANE LABORATORIES INC2004-08-26NDA021648_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021648_001RXDIGOXIN (0.05MG/ML)ORALELIXIRTrue2004-08-26DIGOXIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11b7e5c6e-e052-41b0-a4ce-05dfe62faaaf (view SPL)These highlights do not include all the information needed to use DIGOXIN ORAL SOLUTION, USP safely and effectively. See full prescribing information for DIGOXIN ORAL SOLUTION, USP.DIGOXIN oral solution, USPInitial U.S. Approval: 1982prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2015-07-3110000540057
27b03a2d7-f17c-4954-85c9-fb78cfec7d76 (view SPL)These highlights do not include all the information needed to use Digoxin Oral Solution, USP safely and effectively. See full prescribing information for Digoxin Oral Solution, USP. Digoxin Oral Solution, USP Initial U.S. Approval : 1982prescriptionHuman PrescriptionPrecision Dose Inc.2014-01-242680940752
3dcf907d9-0f0e-4ecc-a555-7e6dcc08c166 (view SPL)These highlights do not include all the information needed to use Digoxin Oral Solution safely and effectively. See full prescribing information for Digoxin Oral Solution. Initial U.S. Approval: 1982prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2011-11-216178560057

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