Mebendazole Chewable Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
1996-04-04
License(s)
ANDA
RxNORM
CHEWABLE TABLET\MEBENDAZOLE
FDAOB
ORAL\TABLET, CHEWABLE\MEBENDAZOLE
SPL Active
ORAL\TABLET, CHEWABLE\MEBENDAZOLE
SPL Moiety
ORAL\TABLET, CHEWABLE\MEBENDAZOLE

product(s) by strength(s)

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683732ANDAPhysicians Total Care, Inc.1996-04-04MEBENDAZOLEORALTABLET, CHEWABLE000939107ANDA073580fa778759-2b9a-4446-ba06-d3c486019e79
2636291528ANDABryant Ranch Prepack2010-04-28MEBENDAZOLEORALTABLET, CHEWABLE000939107ANDA073580c338415f-41e0-071d-8c51-a80a02ebf2cd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073580MEBENDAZOLEAMEDRA PHARMACEUTICALS LLC1995-01-04ANDA073580_001
2NDA017481VERMOXTrueJANSSEN PHARMACEUTICALS INCNDA017481_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA073580_001RXMEBENDAZOLE (100MG)ORALTABLET, CHEWABLETrue1995-01-04MEBENDAZOLE
2NDA017481_001discontinuedMEBENDAZOLE (100MG)ORALTABLET, CHEWABLEFalseVERMOX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1c338415f-41e0-071d-8c51-a80a02ebf2cd (view SPL)MEBENDAZOLE TABLETS, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636291528
2fa778759-2b9a-4446-ba06-d3c486019e79 (view SPL)MEBENDAZOLE TABLETS, USP 100 mg9107prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-04-291548683732

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