Albendazole Oral Tablet

Brand(s)
Albenza
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amedra Pharmaceuticals Llc (2015-06-18)
Oldest Current Product
1996-06-11
License(s)
NDA
RxNORM
ORAL TABLET\ALBENDAZOLE
FDAOB
ORAL\TABLET\ALBENDAZOLE
SPL Active
ORAL\TABLET, FILM COATED\ALBENDAZOLE
SPL Moiety
ORAL\TABLET, FILM COATED\ALBENDAZOLE

product(s) by strength(s)

albendazole 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1520540550AlbenzaNDAAmedra Pharmaceuticals Llc1996-06-11ALBENDAZOLEORALTABLET, FILM COATEDNDA020666e8941166-b77d-45aa-a6e8-04f1c0afd845

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1650840462AlbenzaNDARxpak Division Of Mckesson Corporation1996-06-11ALBENDAZOLEORALTABLET, FILM COATED520540550NDA020666ff679b27-bdf5-4ccc-a57e-6a4d7e77d90c

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020666ALBENZAAMEDRA PHARMACEUTICALS LLC1996-06-11NDA020666_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020666_001RXALBENDAZOLE (200MG)ORALTABLETTrue1996-06-11ALBENZA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1e8941166-b77d-45aa-a6e8-04f1c0afd845 (view SPL)These highlights do not include all the information needed to use ALBENZA safely and effectively. See full prescribing information for ALBENZA. ALBENZA (albendazole) tablets, for oral use ALBENZA (albendazole) chewable tablets, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAmedra Pharmaceuticals Llc2015-06-188520540550, 520540551Albendazole Chewable Tablet
2ff679b27-bdf5-4ccc-a57e-6a4d7e77d90c (view SPL)ALBENZA (albendazole) Tablets Rx onlyprescriptionHuman PrescriptionRxpak Division Of Mckesson CorporationREPACK2014-09-111650840462

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