Albendazole Chewable Tablet

Brand(s)
Albenza
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amedra Pharmaceuticals Llc (2015-06-18)
Oldest Current Product
2015-09-03
License(s)
NDA
RxNORM
CHEWABLE TABLET\ALBENDAZOLE
FDAOB
ORAL\TABLET, CHEWABLE\ALBENDAZOLE
SPL Active
ORAL\TABLET, CHEWABLE\ALBENDAZOLE
SPL Moiety
ORAL\TABLET, CHEWABLE\ALBENDAZOLE

product(s) by strength(s)

albendazole 200 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1520540551AlbenzaNDAAmedra Pharmaceuticals Llc2015-09-032015-09-03ALBENDAZOLEORALTABLET, CHEWABLENDA207844e8941166-b77d-45aa-a6e8-04f1c0afd845

application(s)

#idtitleapplicantapprovedapproved drug
1NDA207844ALBENZAAMEDRA PHARMACEUTICALS LLC2015-06-11NDA207844_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207844_001RXALBENDAZOLE (200MG)ORALTABLET, CHEWABLETrue2015-06-11ALBENZA

spl(s)

#idtitlecategorytypelabelerlast 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 Llc2015-06-188520540551, 520540550Albendazole Oral Tablet

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