Codeine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2012-06-01
License(s)
NDA
RxNORM
ORAL SOLUTION\CODEINE
FDAOB
ORAL\SOLUTION\CODEINE SULFATE
SPL Active
ORAL\SOLUTION\CODEINE SULFATE
SPL Moiety
ORAL\SOLUTION\CODEINE ANHYDROUS

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1512240300NDATagi Pharma, Inc.2012-06-012017-01-07CODEINE SULFATEORALSOLUTIONNDA20224582ce83dd-6b7c-4efa-9ad4-d31ddc1b4517
2680940760NDAPrecision Dose Inc.2013-02-25CODEINE SULFATEORALSOLUTION512240300NDA202245144ce866-0f25-44db-9536-b9d2cec2b022
3680940761NDAPrecision Dose Inc.2013-02-26CODEINE SULFATEORALSOLUTION512240300NDA2022453b04ed3f-1a3d-4e8f-b91b-216c63d40b88

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA202245CODEINE SULFATETrueROXANE LABORATORIES INC2011-06-30NDA202245_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202245_001discontinuedCODEINE SULFATE (30MG/5ML)ORALSOLUTIONFalse2011-06-30CODEINE SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1144ce866-0f25-44db-9536-b9d2cec2b022 (view SPL)These highlights do not include all the information needed to use CODEINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for CODEINE SULFATE ORAL SOLUTION. CODEINE SULFATE ORAL SOLUTION CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionPrecision Dose Inc.2013-07-011680940760
23b04ed3f-1a3d-4e8f-b91b-216c63d40b88 (view SPL)These highlights do not include all the information needed to use CODEINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for CODEINE SULFATE ORAL SOLUTION. CODEINE SULFATE ORAL SOLUTION CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionPrecision Dose Inc.2013-06-281680940761
382ce83dd-6b7c-4efa-9ad4-d31ddc1b4517 (view SPL)These highlights do not include all the information needed to use CODEINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for CODEINE SULFATE ORAL SOLUTION. CODEINE SULFATE ORAL SOLUTION CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionTagi Pharma, Inc.MANUFACTURE2015-01-073512240300

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