Griseofulvin Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2014-05-08)
Oldest Current Product
2006-01-16
License(s)
ANDA
RxNORM
ORAL SUSPENSION\GRISEOFULVIN
FDAOB
ORAL\SUSPENSION\GRISEOFULVIN, MICROSIZE
SPL Active
ORAL\SUSPENSION\GRISEOFULVIN
SPL Moiety
ORAL\SUSPENSION\GRISEOFULVIN

product(s) by strength(s)

griseofulvin 25 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937102ANDATeva Pharmaceuticals Usa Inc2008-02-12GRISEOFULVINORALSUSPENSIONANDA0653548782397b-92e9-4b14-b194-a11fc2294abc
2004720013ANDAActavis Pharma, Inc.2007-07-26GRISEOFULVINORALSUSPENSIONANDA065394af318d5d-cc39-4a63-a590-b87c50f2694f
3006039171ANDAQualitest Pharmaceuticals2010-10-08GRISEOFULVINORALSUSPENSIONANDA0654384bb379b4-fdbd-49db-9f79-18583a7cac57
4458020968ANDAPerrigo New York Inc2008-07-16GRISEOFULVINORALSUSPENSIONANDA065200b394ee74-53e5-493a-8ed9-95d3e8a10e88

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685234ANDAPhysicians Total Care, Inc.2006-01-16GRISEOFULVINORALSUSPENSION101470810ANDA06248382f52d21-eacd-4edf-8ad5-a8ef090ffa2a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540306ANDARebel Distributors Corp2007-07-26GRISEOFULVINORALSUSPENSION004720013ANDA065394f1153794-33ae-4e9d-8c80-d29e01f82d77

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062483GRIFULVIN VTrueVALEANT PHARMACEUTICALS LUXEMBOURG SARL1984-01-26ANDA062483_001
2ANDA065200GRISEOFULVINPERRIGO CO TENNESSEE INC2005-03-02ANDA065200_001
3ANDA065354GRISEOFULVINIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2007-09-10ANDA065354_001
4ANDA065394GRISEOFULVINACTAVIS MID ATLANTIC LLC2007-07-06ANDA065394_001
5ANDA065438GRISEOFULVINVINTAGE PHARMACEUTICALS2010-10-08ANDA065438_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062483_001discontinuedGRISEOFULVIN, MICROSIZE (125MG/5ML)ORALSUSPENSIONFalse1984-01-26GRIFULVIN V
2ANDA065200_001RXGRISEOFULVIN, MICROSIZE (125MG/5ML)ORALSUSPENSIONFalseAB2005-03-02GRISEOFULVIN
3ANDA065354_001RXGRISEOFULVIN, MICROSIZE (125MG/5ML)ORALSUSPENSIONFalseAB2007-09-10GRISEOFULVIN
4ANDA065394_001RXGRISEOFULVIN, MICROSIZE (125MG/5ML)ORALSUSPENSIONTrueAB2007-07-06GRISEOFULVIN
5ANDA065438_001RXGRISEOFULVIN, MICROSIZE (125MG/5ML)ORALSUSPENSIONFalseAB2010-10-08GRISEOFULVIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14bb379b4-fdbd-49db-9f79-18583a7cac57 (view SPL)GRISEOFULVIN ORAL SUSPENSION, USP Microsize 125 mg/5 mL Rx onlyprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-04-134006039171
282f52d21-eacd-4edf-8ad5-a8ef090ffa2a (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-10-251548685234
38782397b-92e9-4b14-b194-a11fc2294abc (view SPL)GRISEOFULVIN ORAL SUSPENSION USP (microsize) 7102 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-06-263000937102
4af318d5d-cc39-4a63-a590-b87c50f2694f (view SPL)GRISEOFULVIN ORAL SUSPENSION USP(microsize), 125 mg/5 mL Rx OnlyprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-05-086004720013
5b394ee74-53e5-493a-8ed9-95d3e8a10e88 (view SPL)Griseofulvin Oral Suspension, USPprescriptionHuman PrescriptionPerrigo New York Inc2011-09-024458020968
6f1153794-33ae-4e9d-8c80-d29e01f82d77 (view SPL)GRISEOFULVIN ORAL SUSPENSION (microsize) USP, 125 mg/5 mL Rx OnlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-09-261422540306

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