Ketoprofen Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-08-10)
Oldest Current Product
1993-01-01
License(s)
ANDA
RxNORM
ORAL CAPSULE\KETOPROFEN
FDAOB
ORAL\CAPSULE\KETOPROFEN
SPL Active
ORAL\CAPSULE\KETOPROFEN
SPL Moiety
ORAL\CAPSULE\KETOPROFEN

product(s) by strength(s)

ketoprofen 50 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933193ANDATeva Pharmaceuticals Usa Inc1993-01-01KETOPROFENORALCAPSULEANDA073516c2c99853-1268-4998-a44b-2bf0c0b70fd2
2003784070ANDAMylan Pharmaceuticals Inc.1997-01-15KETOPROFENORALCAPSULEANDA074035198a4140-f4c0-4478-9157-ee1d68d0bb96

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900136ANDAStat Rx Usa Llc2011-01-18KETOPROFENORALCAPSULE000933193ANDA0735166b36cfde-9ecd-4532-88ee-14261f729d06
2216950340ANDARebel Distributors Corp2010-04-20KETOPROFENORALCAPSULE003784070ANDA0740359bc31f67-cfce-4ad6-9c07-3845ead3542c
3422910360ANDAAvkare, Inc.2013-07-08KETOPROFENORALCAPSULE000933193ANDA0735160de3afde-dd2f-4f26-7141-82a77ab5ea41
4529590245ANDAH.J. Harkins Company, Inc.2011-01-18KETOPROFENORALCAPSULE000933193ANDA073516f9d258bc-2ae3-4cc8-a5d4-987164c1e0b4
5548682414ANDAPhysicians Total Care, Inc.1997-02-14KETOPROFENORALCAPSULE003784070ANDA074035b3180408-a3c0-4e02-8535-dea390a52277
6552890287ANDAPd-Rx Pharmaceuticals, Inc.2010-04-20KETOPROFENORALCAPSULE003784070ANDA074035b7967cca-921e-49af-b64b-78c87ca7f776
7636293642ANDABryant Ranch Prepack2011-01-18KETOPROFENORALCAPSULE000933193ANDA07351679f475c8-f978-c0ee-b900-f270b59c492d

ketoprofen 75 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933195ANDATeva Pharmaceuticals Usa Inc1993-01-01KETOPROFENORALCAPSULEANDA073517c2c99853-1268-4998-a44b-2bf0c0b70fd2
2003785750ANDAMylan Pharmaceuticals Inc.1997-01-15KETOPROFENORALCAPSULEANDA074035198a4140-f4c0-4478-9157-ee1d68d0bb96

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900137ANDAStat Rx Usa Llc2011-01-18KETOPROFENORALCAPSULE000933195ANDA0735176b36cfde-9ecd-4532-88ee-14261f729d06
2216950341ANDARebel Distributors Corp2010-04-20KETOPROFENORALCAPSULE003785750ANDA0740359bc31f67-cfce-4ad6-9c07-3845ead3542c
3332610064ANDAAidarex Pharmaceuticals Llc1993-01-01KETOPROFENORALCAPSULE000933195ANDA0735174bfd7816-73c1-49c4-833e-a8e5a6a7bd64
4422540037ANDARebel Distributors Corp2011-01-18KETOPROFENORALCAPSULE000933195ANDA07351751f3222f-bc05-4117-881d-85880b092e42
5422910361ANDAAvkare, Inc.2013-07-08KETOPROFENORALCAPSULE000933195ANDA0735170de3afde-dd2f-4f26-7141-82a77ab5ea41
6545693688ANDAA-S Medication Solutions Llc1993-01-01KETOPROFENORALCAPSULE000933195ANDA073517808762a0-1595-4b00-85f4-bb9b57590c22
7548682415ANDAPhysicians Total Care, Inc.2005-08-15KETOPROFENORALCAPSULE003785750ANDA074035b3180408-a3c0-4e02-8535-dea390a52277
8552890181ANDAPd-Rx Pharmaceuticals, Inc.2011-01-18KETOPROFENORALCAPSULE000933195ANDA073517f0d14edb-7e04-4155-8034-1bed7f0318b0
9631870018ANDAProficient Rx Lp1993-01-01KETOPROFENORALCAPSULE000933195ANDA0735175b9c497c-5e32-4c77-82ab-fe6abdd9cf57
10636291836ANDABryant Ranch Prepack2011-01-18KETOPROFENORALCAPSULE000933195ANDA073517ecf6bc02-233d-2c3b-1ba0-e5d708338e45
11687889088ANDAPreferred Pharmaceuticals, Inc.2011-01-18KETOPROFENORALCAPSULE000933195ANDA073517dc21a4f9-d8f3-4804-ba3e-a26cae143f26

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073515KETOPROFENTrueTEVA PHARMACEUTICALS USA INC1992-12-22ANDA073515_001
2ANDA073516KETOPROFENTEVA PHARMACEUTICALS USA INC1992-12-22ANDA073516_001
3ANDA073517KETOPROFENTEVA PHARMACEUTICALS USA INC1992-12-22ANDA073517_001
4ANDA074014KETOPROFENDORADO PHARMA LLC1993-01-29ANDA074014_001, ANDA074014_002, ANDA074014_003
5ANDA074024KETOPROFENTrueSANDOZ INC1995-12-29ANDA074024_001, ANDA074024_002
6ANDA074035KETOPROFENMYLAN PHARMACEUTICALS INC1996-12-31ANDA074035_002, ANDA074035_003
7NDA018754ORUDISTrueWYETH AYERST LABORATORIES1986-01-09NDA018754_001, NDA018754_002, NDA018754_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073515_001discontinuedKETOPROFEN (25MG)ORALCAPSULEFalse1992-12-22KETOPROFEN
2ANDA073516_001RXKETOPROFEN (50MG)ORALCAPSULEFalseAB1992-12-22KETOPROFEN
3ANDA073517_001RXKETOPROFEN (75MG)ORALCAPSULETrueAB1992-12-22KETOPROFEN
4ANDA074014_001RXKETOPROFEN (25MG)ORALCAPSULEFalse1993-01-29KETOPROFEN
5ANDA074014_002RXKETOPROFEN (50MG)ORALCAPSULEFalseAB1993-01-29KETOPROFEN
6ANDA074014_003RXKETOPROFEN (75MG)ORALCAPSULEFalseAB1993-01-29KETOPROFEN
7ANDA074024_001discontinuedKETOPROFEN (50MG)ORALCAPSULEFalse1995-12-29KETOPROFEN
8ANDA074024_002discontinuedKETOPROFEN (75MG)ORALCAPSULEFalse1995-12-29KETOPROFEN
9ANDA074035_002RXKETOPROFEN (50MG)ORALCAPSULEFalseAB1996-12-31KETOPROFEN
10ANDA074035_003RXKETOPROFEN (75MG)ORALCAPSULEFalseAB1996-12-31KETOPROFEN
11NDA018754_001discontinuedKETOPROFEN (25MG)ORALCAPSULEFalse1987-07-31ORUDIS
12NDA018754_002discontinuedKETOPROFEN (50MG)ORALCAPSULEFalse1986-01-09ORUDIS
13NDA018754_003discontinuedKETOPROFEN (75MG)ORALCAPSULEFalse1986-01-09ORUDIS

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10de3afde-dd2f-4f26-7141-82a77ab5ea41 (view SPL)KETOPROFEN CAPSULESOT360Ketoprofen Capsules50 mg and 75 mgRx OnlyMfg. Rev. B 07/09AV 02/13 (P)prescriptionHuman PrescriptionAvkare, Inc.2013-07-081422910360, 422910361
2198a4140-f4c0-4478-9157-ee1d68d0bb96 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-218003784070, 003785750, 003788200Ketoprofen Extended Release Oral Capsule
34bfd7816-73c1-49c4-833e-a8e5a6a7bd64 (view SPL)KETOPROFEN CAPSULES31933195Rx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-051332610064
451f3222f-bc05-4117-881d-85880b092e42 (view SPL)KETOPROFEN CAPSULESRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-131422540037
55b9c497c-5e32-4c77-82ab-fe6abdd9cf57 (view SPL)KETOPROFEN CAPSULES 3193 3195 Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-301631870018
66b36cfde-9ecd-4532-88ee-14261f729d06 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-06-141165900136, 165900137
779f475c8-f978-c0ee-b900-f270b59c492d (view SPL)KETOPROFEN CAPSULESprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2011-01-182636293642
8808762a0-1595-4b00-85f4-bb9b57590c22 (view SPL)KETOPROFEN CAPSULES31933195Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-261545693688
99bc31f67-cfce-4ad6-9c07-3845ead3542c (view SPL)KetoprofenprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-281216950340, 216950341
10b3180408-a3c0-4e02-8535-dea390a52277 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-267548682414, 548682415, 548684826Ketoprofen Extended Release Oral Capsule
11b7967cca-921e-49af-b64b-78c87ca7f776 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-06-044552890287
12c2c99853-1268-4998-a44b-2bf0c0b70fd2 (view SPL)KETOPROFEN CAPSULES USP 31933195 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-106000933193, 000933195
13dc21a4f9-d8f3-4804-ba3e-a26cae143f26 (view SPL)KETOPROFEN CAPSULES 3193 3195 Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-133687889088
14ecf6bc02-233d-2c3b-1ba0-e5d708338e45 (view SPL)KETOPROFEN CAPSULESprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-183636291836
15f0d14edb-7e04-4155-8034-1bed7f0318b0 (view SPL)KETOPROFEN CAPSULES31933195Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-183552890181
16f9d258bc-2ae3-4cc8-a5d4-987164c1e0b4 (view SPL)KETOPROFEN CAPSULES31933195Rx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-08-292529590245

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