Ketoprofen Extended Release Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-07-21)
Oldest Current Product
2003-09-04
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\KETOPROFEN
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\KETOPROFEN
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\KETOPROFEN
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\KETOPROFEN

product(s) by strength(s)

24 hr ketoprofen 200 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003788200ANDAMylan Pharmaceuticals Inc.2003-09-04KETOPROFENORALCAPSULE, EXTENDED RELEASEANDA075679198a4140-f4c0-4478-9157-ee1d68d0bb96

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684826ANDAPhysicians Total Care, Inc.2009-06-23KETOPROFENORALCAPSULE, EXTENDED RELEASE003788200ANDA075679b3180408-a3c0-4e02-8535-dea390a52277

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074879KETOPROFENTrueALKERMES GAINESVILLE LLC1997-12-10ANDA074879_001
2ANDA075270KETOPROFENACTAVIS LABORATORIES FL INC1999-03-24ANDA075270_001, ANDA075270_002, ANDA075270_003
3ANDA075679KETOPROFENMYLAN PHARMACEUTICALS INC2002-02-20ANDA075679_001, ANDA075679_002, ANDA075679_003
4NDA019816ORUVAILTrueWYETH PHARMACEUTICALS INC1993-09-24NDA019816_001, NDA019816_002, NDA019816_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074879_001discontinuedKETOPROFEN (200MG)ORALCAPSULE, EXTENDED RELEASEFalse1997-12-10KETOPROFEN
2ANDA075270_001RXKETOPROFEN (200MG)ORALCAPSULE, EXTENDED RELEASEFalseAB1999-03-24KETOPROFEN
3ANDA075270_002RXKETOPROFEN (100MG)ORALCAPSULE, EXTENDED RELEASEFalseAB1999-03-24KETOPROFEN
4ANDA075270_003RXKETOPROFEN (150MG)ORALCAPSULE, EXTENDED RELEASEFalseAB1999-03-24KETOPROFEN
5ANDA075679_001RXKETOPROFEN (200MG)ORALCAPSULE, EXTENDED RELEASETrueAB2002-02-20KETOPROFEN
6ANDA075679_002RXKETOPROFEN (150MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2002-02-20KETOPROFEN
7ANDA075679_003RXKETOPROFEN (100MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2002-02-20KETOPROFEN
8NDA019816_001discontinuedKETOPROFEN (200MG)ORALCAPSULE, EXTENDED RELEASEFalse1993-09-24ORUVAIL
9NDA019816_002discontinuedKETOPROFEN (150MG)ORALCAPSULE, EXTENDED RELEASEFalse1995-02-08ORUVAIL
10NDA019816_003discontinuedKETOPROFEN (100MG)ORALCAPSULE, EXTENDED RELEASEFalse1995-02-08ORUVAIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1198a4140-f4c0-4478-9157-ee1d68d0bb96 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-218003788200, 003784070, 003785750Ketoprofen Oral Capsule
2b3180408-a3c0-4e02-8535-dea390a52277 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-267548684826, 548682414, 548682415Ketoprofen Oral Capsule

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