Flurbiprofen Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2009-06-17)
Oldest Current Product
1994-06-20
License(s)
ANDA
RxNORM
ORAL TABLET\FLURBIPROFEN
FDAOB
ORAL\TABLET\FLURBIPROFEN
SPL Active
ORAL\TABLET, FILM COATED\FLURBIPROFEN
SPL Moiety
ORAL\TABLET, FILM COATED\FLURBIPROFEN

product(s) by strength(s)

flurbiprofen 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930711ANDATeva Pharmaceuticals Usa Inc1995-06-02FLURBIPROFENORALTABLET, FILM COATEDANDA0744314e5c06f1-f279-4f2f-b10d-0f70005a27e6
2003780093ANDAMylan Pharmaceuticals Inc.1994-06-20FLURBIPROFENORALTABLET, FILM COATEDANDA07435886b915c9-9c00-46c2-8dd9-3e15a6b42323

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900096ANDAStat Rx Usa Llc1994-06-20FLURBIPROFENORALTABLET, FILM COATED003780093ANDA0743589ce60fd6-b58b-4b7c-835d-305107552f44
2353560710ANDALake Erie Medical Dba Quality Care Products Llc2011-05-20FLURBIPROFENORALTABLET, FILM COATED003780093ANDA0743580b9894ea-6e23-413c-a4ff-c7f7f7dc994d
3499990311ANDALake Erie Medical Dba Quality Care Products Llc2012-03-07FLURBIPROFENORALTABLET, FILM COATED000930711ANDA074431625fe103-aa38-49f0-b2c5-b6758c010670
4548683362ANDAPhysicians Total Care, Inc.1997-02-24FLURBIPROFENORALTABLET, FILM COATED003780093ANDA074358c9449292-e81e-486a-84e1-bb9dd0f612c5
5552890561ANDAPd-Rx Pharmaceuticals, Inc.2011-05-20FLURBIPROFENORALTABLET, FILM COATED003780093ANDA0743589cb00626-0502-428d-ad45-a211764a2f5f
6636291250ANDABryant Ranch Prepack1995-06-02FLURBIPROFENORALTABLET, FILM COATED000930711ANDA074431972b557c-1abb-4032-89f9-2d6cfde422e7

flurbiprofen 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780076ANDAMylan Pharmaceuticals Inc.1994-06-20FLURBIPROFENORALTABLET, FILM COATEDANDA07435886b915c9-9c00-46c2-8dd9-3e15a6b42323

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074358FLURBIPROFENMYLAN PHARMACEUTICALS INC1994-06-20ANDA074358_001, ANDA074358_002
2ANDA074405FLURBIPROFENTrueTEVA PHARMACEUTICALS USA INC1995-05-24ANDA074405_001, ANDA074405_002
3ANDA074411FLURBIPROFENTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-05-31ANDA074411_001, ANDA074411_002
4ANDA074431FLURBIPROFENTEVA PHARMACEUTICALS USA INC1995-05-31ANDA074431_001
5ANDA074448FLURBIPROFENTrueSANDOZ INC1995-07-28ANDA074448_001, ANDA074448_002
6ANDA074560FLURBIPROFENTrueTHERAGEN INC1997-05-16ANDA074560_002
7ANDA074647FLURBIPROFENTruePLIVA INC1997-04-01ANDA074647_001, ANDA074647_002
8ANDA075058FLURBIPROFENSUN PHARMACEUTICAL INDUSTRIES INC2001-04-27ANDA075058_001, ANDA075058_002
9NDA018766ANSAIDTruePHARMACIA AND UPJOHN CO1988-10-31NDA018766_002, NDA018766_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074358_001RXFLURBIPROFEN (50MG)ORALTABLETFalseAB1994-06-20FLURBIPROFEN
2ANDA074358_002RXFLURBIPROFEN (100MG)ORALTABLETTrueAB1994-06-20FLURBIPROFEN
3ANDA074405_001discontinuedFLURBIPROFEN (100MG)ORALTABLETFalse1995-05-24FLURBIPROFEN
4ANDA074405_002discontinuedFLURBIPROFEN (50MG)ORALTABLETFalse1995-05-24FLURBIPROFEN
5ANDA074411_001discontinuedFLURBIPROFEN (50MG)ORALTABLETFalse1995-05-31FLURBIPROFEN
6ANDA074411_002discontinuedFLURBIPROFEN (100MG)ORALTABLETFalse1995-05-31FLURBIPROFEN
7ANDA074431_001RXFLURBIPROFEN (100MG)ORALTABLETFalseAB1995-05-31FLURBIPROFEN
8ANDA074448_001discontinuedFLURBIPROFEN (50MG)ORALTABLETFalse1995-07-28FLURBIPROFEN
9ANDA074448_002discontinuedFLURBIPROFEN (100MG)ORALTABLETFalse1995-07-28FLURBIPROFEN
10ANDA074560_002discontinuedFLURBIPROFEN (100MG)ORALTABLETFalse1997-05-16FLURBIPROFEN
11ANDA074647_001discontinuedFLURBIPROFEN (50MG)ORALTABLETFalse1997-04-01FLURBIPROFEN
12ANDA074647_002discontinuedFLURBIPROFEN (100MG)ORALTABLETFalse1997-04-01FLURBIPROFEN
13ANDA075058_001RXFLURBIPROFEN (50MG)ORALTABLETFalseAB2001-04-27FLURBIPROFEN
14ANDA075058_002RXFLURBIPROFEN (100MG)ORALTABLETFalseAB2001-04-27FLURBIPROFEN
15NDA018766_002discontinuedFLURBIPROFEN (50MG)ORALTABLETFalse1988-10-31ANSAID
16NDA018766_003discontinuedFLURBIPROFEN (100MG)ORALTABLETFalse1988-10-31ANSAID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b9894ea-6e23-413c-a4ff-c7f7f7dc994d (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-06-273878353560710
24e5c06f1-f279-4f2f-b10d-0f70005a27e6 (view SPL)FLURBIPROFEN TABLETS USP, 100 mg0711Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-06-295000930711
3625fe103-aa38-49f0-b2c5-b6758c010670 (view SPL)FLURBIPROFEN TABLETS USP, 100 mg0711Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-03-073626499990311
486b915c9-9c00-46c2-8dd9-3e15a6b42323 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2009-06-176003780076, 003780093
5972b557c-1abb-4032-89f9-2d6cfde422e7 (view SPL)FLURBIPROFEN TABLETS USP, 100 mg0711Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-06-191002636291250
69cb00626-0502-428d-ad45-a211764a2f5f (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-06-173552890561
79ce60fd6-b58b-4b7c-835d-305107552f44 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llc2009-05-151165900096
8c9449292-e81e-486a-84e1-bb9dd0f612c5 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-121548683362

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