Citric Acid / Magnesium Oxide / picosulfate sodium Oral Solution

Brand(s)
Prepopik
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ferring Pharmaceuticals Inc. (2015-11-05)
Oldest Current Product
2014-09-05
License(s)
NDA
RxNORM
ORAL SOLUTION\CITRIC ACID:MAGNESIUM OXIDE:PICOSULFATE SODIUM
FDAOB
ORAL\FOR SOLUTION\CITRIC ACID: MAGNESIUM OXIDE: SODIUM PICOSULFATE
SPL Active
ORAL\POWDER, METERED\ANHYDROUS CITRIC ACID: MAGNESIUM OXIDE: SODIUM PICOSULFATE
SPL Moiety
ORAL\POWDER, METERED\ANHYDROUS CITRIC ACID: MAGNESIUM CATION: PICOSULFURIC ACID

product(s) by strength(s)

citric acid 80 mg/ml / magnesium oxide 23.3 mg/ml / picosulfate sodium 0.0667 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555669700PrepopikNDAFerring Pharmaceuticals Inc.2014-09-05ANHYDROUS CITRIC ACID, MAGNESIUM OXIDE, SODIUM PICOSULFATEORALPOWDER, METEREDNDA20253563e9aeed-31a5-4f22-b3eb-987d38b966f6

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202535PREPOPIKFERRING PHARMACEUTICALS AS2012-07-16p8481083, SUBSTANCE
p8450338, SUBSTANCE
NEW PRODUCT [2015-07-16]NDA202535_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202535_001RXSODIUM PICOSULFATE (10MG/PACKET), MAGNESIUM OXIDE (3.5GM/PACKET), CITRIC ACID (12GM/PACKET)ORALFOR SOLUTIONTrue2012-07-16PREPOPIK

patent(s)

#idexpiration dateapplication(s)
1p8450338 (view patent)2028-10-10NDA202535
2p8481083 (view patent)2028-10-10NDA202535

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
163e9aeed-31a5-4f22-b3eb-987d38b966f6 (view SPL)These highlights do not include all the information needed to use Prepopik safely and effectively. See full prescribing information for Prepopik. Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid) for oral solutionInitial U.S. Approval: 2012prescriptionHuman PrescriptionFerring Pharmaceuticals Inc.LABEL, MANUFACTURE, PACK2015-11-057555669700, 555669300

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