Diflunisal Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-08-12)
Oldest Current Product
1992-11-01
License(s)
ANDA
RxNORM
ORAL TABLET\DIFLUNISAL
FDAOB
ORAL\TABLET\DIFLUNISAL
SPL Active
ORAL\TABLET, FILM COATED\DIFLUNISAL
SPL Moiety
ORAL\TABLET, FILM COATED\DIFLUNISAL

product(s) by strength(s)

diflunisal 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930755ANDATeva Pharmaceuticals Usa Inc1992-11-01DIFLUNISALORALTABLET, FILM COATEDANDA0736737a78bb38-14d8-4a90-b883-482d4cebf716
2649800181ANDARising Pharmaceuticals, Inc.2012-05-01DIFLUNISALORALTABLET, FILM COATEDANDA202845e110f879-98e6-49cb-a3b0-68805cdf602a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545693658ANDAA-S Medication Solutions Llc1992-11-01DIFLUNISALORALTABLET, FILM COATED000930755ANDA0736731525d679-0e56-4d42-8252-bdff74d7c7e2
2548683049ANDAPhysicians Total Care, Inc.2009-07-21DIFLUNISALORALTABLET, FILM COATED000930755ANDA073673ea8ce5e2-dad4-4288-a1e1-775ea98a6fb9
3552890460ANDAPd-Rx Pharmaceuticals, Inc.2010-08-20DIFLUNISALORALTABLET, FILM COATED000930755ANDA07367393bc2682-30e3-42b7-9eae-fd75234a2e6c
4681510848ANDACarilion Materials Management1992-11-01DIFLUNISALORALTABLET, FILM COATED000930755ANDA0736733baf108a-e9c1-4a2a-8e69-34aa69af1de3

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073562DIFLUNISALTrueROXANE LABORATORIES INC1992-11-27ANDA073562_001
2ANDA073563DIFLUNISALTrueROXANE LABORATORIES INC1992-11-27ANDA073563_001
3ANDA073673DIFLUNISALTEVA PHARMACEUTICALS USA INC1992-07-31ANDA073673_001
4ANDA073679DIFLUNISALTrueTEVA PHARMACEUTICALS USA INC1992-07-31ANDA073679_001
5ANDA074285DIFLUNISALTruePUREPAC PHARMACEUTICAL CO1996-05-07ANDA074285_001, ANDA074285_002
6ANDA074400DIFLUNISALTrueWATSON LABORATORIES INC1997-07-17ANDA074400_001, ANDA074400_002
7ANDA074604DIFLUNISALTrueSANDOZ INC1996-06-10ANDA074604_001
8ANDA202845DIFLUNISALHERITAGE PHARMA LABS INC2012-03-08ANDA202845_001
9NDA018445DOLOBIDTrueMERCK AND CO INC1982-04-19NDA018445_001, NDA018445_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073562_001discontinuedDIFLUNISAL (250MG)ORALTABLETFalse1992-11-27DIFLUNISAL
2ANDA073563_001discontinuedDIFLUNISAL (500MG)ORALTABLETFalse1992-11-27DIFLUNISAL
3ANDA073673_001RXDIFLUNISAL (500MG)ORALTABLETTrueAB1992-07-31DIFLUNISAL
4ANDA073679_001discontinuedDIFLUNISAL (250MG)ORALTABLETFalse1992-07-31DIFLUNISAL
5ANDA074285_001discontinuedDIFLUNISAL (250MG)ORALTABLETFalse1996-05-07DIFLUNISAL
6ANDA074285_002discontinuedDIFLUNISAL (500MG)ORALTABLETFalse1996-05-07DIFLUNISAL
7ANDA074400_001discontinuedDIFLUNISAL (250MG)ORALTABLETFalse1997-07-17DIFLUNISAL
8ANDA074400_002discontinuedDIFLUNISAL (500MG)ORALTABLETFalse1997-07-17DIFLUNISAL
9ANDA074604_001discontinuedDIFLUNISAL (500MG)ORALTABLETFalse1996-06-10DIFLUNISAL
10ANDA202845_001RXDIFLUNISAL (500MG)ORALTABLETFalseAB2012-03-08DIFLUNISAL
11NDA018445_001discontinuedDIFLUNISAL (250MG)ORALTABLETFalse1982-04-19DOLOBID
12NDA018445_002discontinuedDIFLUNISAL (500MG)ORALTABLETFalse1982-04-19DOLOBID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11525d679-0e56-4d42-8252-bdff74d7c7e2 (view SPL)DIFLUNISAL TABLETS USP0755Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-261545693658
23baf108a-e9c1-4a2a-8e69-34aa69af1de3 (view SPL)DIFLUNISAL TABLETS USP 0755 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-08-032681510848
37a78bb38-14d8-4a90-b883-482d4cebf716 (view SPL)DIFLUNISAL TABLETS USP0755Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-125000930755
493bc2682-30e3-42b7-9eae-fd75234a2e6c (view SPL)DIFLUNISAL TABLETS USP0755Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-08-204552890460
5e110f879-98e6-49cb-a3b0-68805cdf602a (view SPL)Rx onlyprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.analysis, label, manufacture, pack2015-03-104649800181
6ea8ce5e2-dad4-4288-a1e1-775ea98a6fb9 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-08-114548683049

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