sodium phosphate Oral Tablet

Brand(s)
OsmoPrep
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Salix Pharmaceuticals, Inc. (2013-03-27)
Oldest Current Product
2006-05-15
License(s)
NDA
RxNORM
ORAL TABLET\SODIUM PHOSPHATE
FDAOB
ORAL\TABLET\SODIUM PHOSPHATE, DIBASIC, ANHYDROUS: SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SPL Active
ORAL\TABLET\SODIUM PHOSPHATE, DIBASIC, ANHYDROUS: SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SPL Moiety
ORAL\TABLET\PHOSPHATE ION
ORAL\TABLET\SODIUM CATION

product(s) by strength(s)

sodium phosphate 1500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490701OsmoPrepNDASalix Pharmaceuticals, Inc.2006-05-15SODIUM PHOSPHATE, DIBASIC, ANHYDROUS, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEORALTABLETNDA021892b46c0b17-c49b-4791-913f-3e6e1fdbe88e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685889OsmoPrepNDAPhysicians Total Care, Inc.2008-05-30SODIUM PHOSPHATE, DIBASIC, ANHYDROUS, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEORALTABLET656490701NDA021892983ce15f-cd37-4f3a-9e51-205860e80976

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA079247MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATETrueNOVEL LABORATORIES INC2011-12-30ANDA079247_001
2NDA021892OSMOPREPSALIX PHARMACEUTICALS INC2006-03-16p7687075, SUBSTANCENDA021892_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA079247_001discontinuedSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (0.398GM), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (1.102GM)ORALTABLETFalse2011-12-30MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
2NDA021892_001RXSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (1.102GM), SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (0.398GM)ORALTABLETTrue2006-03-16OSMOPREP

patent(s)

#idexpiration dateapplication(s)
1p7687075 (view patent)2028-06-22NDA021892

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1983ce15f-cd37-4f3a-9e51-205860e80976 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-043548685889
2b46c0b17-c49b-4791-913f-3e6e1fdbe88e (view SPL)These highlights do not include all the information needed to useOSMOPREP safely and effectively. See full prescribing information for OSMOPREP. OSMOPREP(sodium phosphate, monobasic, monohydrate, sodium phosphate, dibasic anhydrous)Tablets for oral use Initial U.S. Approval: 2006prescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.2013-03-2720656490701

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