Clotrimazole Oral Lozenge

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2013-09-01)
Oldest Current Product
2004-07-29
License(s)
ANDA
RxNORM
ORAL LOZENGE\CLOTRIMAZOLE
FDAOB
ORAL\TROCHE/LOZENGE\CLOTRIMAZOLE\rdfq
SPL Active
ORAL\LOZENGE\CLOTRIMAZOLE
SPL Moiety
ORAL\LOZENGE\CLOTRIMAZOLE

product(s) by strength(s)

clotrimazole 10 mg oral lozenge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544146ANDARoxane Laboratories, Inc2004-07-29CLOTRIMAZOLEORALLOZENGEANDA0763870bc4b876-ddee-4f03-b44f-544348739a26
2000548146ANDARoxane Laboratories, Inc2004-07-29CLOTRIMAZOLEORALLOZENGEANDA0763870bc4b876-ddee-4f03-b44f-544348739a26
3005740107ANDAPaddock Laboratories, Llc2005-12-01CLOTRIMAZOLEORALLOZENGEANDA0767633f57ef51-8202-4d0b-95a8-d2df468b8d9a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250146ANDARemedyrepack Inc.2013-03-25CLOTRIMAZOLEORALLOZENGE000544146ANDA076387a2b013c6-1503-4d10-a534-2b4d1036b318
2548685463ANDAPhysicians Total Care, Inc.2009-07-23CLOTRIMAZOLEORALLOZENGE005740107ANDA076763eacf7456-5f44-483d-8b5f-c2c273f46e76
3551544951ANDACardinal Health2004-07-29CLOTRIMAZOLEORALLOZENGE000548146ANDA0763879f6b9cba-c90a-4aee-9a73-eaeffb455f97

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076387CLOTRIMAZOLEROXANE LABORATORIES INC2004-07-29ANDA076387_001
2ANDA076763CLOTRIMAZOLEPADDOCK LABORATORIES LLC2005-10-28ANDA076763_001
3NDA018713MYCELEXTrueBAYER HEALTHCARE PHARMACEUTICALS INC1983-06-17NDA018713_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routerldTEapprovedapplication
1ANDA076387_001RXCLOTRIMAZOLE (10MG)ORALTrueAB2004-07-29CLOTRIMAZOLE
2ANDA076763_001RXCLOTRIMAZOLE (10MG)ORALFalseAB2005-10-28CLOTRIMAZOLE
3NDA018713_001discontinuedCLOTRIMAZOLE (10MG)ORALFalse1983-06-17MYCELEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10bc4b876-ddee-4f03-b44f-544348739a26 (view SPL)CLOTRIMAZOLE TROCHE (clotrimazole lozenges) USPprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2013-09-019000544146, 000548146
23f57ef51-8202-4d0b-95a8-d2df468b8d9a (view SPL)Clotrimazole Lozenge ( Clotrimazole Troche)prescriptionHuman PrescriptionPaddock Laboratories, Llc2013-11-133005740107
39f6b9cba-c90a-4aee-9a73-eaeffb455f97 (view SPL)CLOTRIMAZOLE TROCHE (clotrimazole lozenges) USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-225551544951
4a2b013c6-1503-4d10-a534-2b4d1036b318 (view SPL)CLOTRIMAZOLE TROCHE(clotrimazole lozenges)prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-251521250146
5eacf7456-5f44-483d-8b5f-c2c273f46e76 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-10-222548685463

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