Alendronate Effervescent Oral Tablet

Brand(s)
Binosto
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mission Pharmacal Company (2015-02-28)
Oldest Current Product
2012-09-03
License(s)
NDA
RxNORM
EFFERVESCENT ORAL TABLET\ALENDRONATE
FDAOB
ORAL\TABLET, EFFERVESCENT\ALENDRONATE SODIUM
SPL Active
ORAL\TABLET, EFFERVESCENT\ALENDRONATE SODIUM
SPL Moiety
ORAL\TABLET, EFFERVESCENT\ALENDRONIC ACID

product(s) by strength(s)

alendronic acid 70 mg effervescent oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001780101BinostoNDAMission Pharmacal Company2012-09-03ALENDRONATE SODIUMORALTABLET, EFFERVESCENTNDA202344ad670460-141b-e481-f713-7aed9485de8d

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA202344BINOSTOMISSION PHARMACAL CO2012-03-12p7964212, SUBSTANCE
p7488496, SUBSTANCE
NDA202344_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202344_001RXALENDRONATE SODIUM (EQ 70MG BASE)ORALTABLET, EFFERVESCENTTrue2012-03-12BINOSTO

patent(s)

#idexpiration dateapplication(s)
1p7488496 (view patent)2023-08-11NDA202344
2p7964212 (view patent)2023-03-06NDA202344

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ad670460-141b-e481-f713-7aed9485de8d (view SPL)These highlights do not include all the information needed to use BINOSTO safely and effectively. See full prescribing information for BINOSTO.BINOSTO (alendronate sodium) effervescent tablets for oral solutionInitial U.S. Approval: 1995prescriptionHuman PrescriptionMission Pharmacal CompanyMANUFACTURE2015-02-287001780101

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