FDA.reportPublic FDA data

Application 020998

Type
NDA
Sponsor
GD SEARLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELEBREXCELECOXIBCAPSULE;ORAL100MGYesNo
002CELEBREXCELECOXIBCAPSULE;ORAL200MGYesNo
003CELEBREXCELECOXIBCAPSULE;ORAL400MGYesYes
004CELEBREXCELECOXIBCAPSULE;ORAL50MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1515CELEBREXCelecoxibPfizer Laboratories Div Pfizer IncNDACurrent
0025-1515CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1515CELEBREXCelecoxibPfizer Laboratories Div Pfizer IncNDACurrent
0025-1515CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1515CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1520CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1520CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1520CELEBREXCelecoxibPfizer Laboratories Div Pfizer IncNDACurrent
0025-1520CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1520CELEBREXCelecoxibPfizer Laboratories Div Pfizer IncNDACurrent
0025-1525CELEBREXCelecoxibPfizer Laboratories Div Pfizer IncNDACurrent
0025-1525CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1525CELEBREXCelecoxibPfizer Laboratories Div Pfizer IncNDACurrent
0025-1525CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1525CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1530CELEBREXCelecoxibPfizer Laboratories Div Pfizer IncNDACurrent
0025-1530CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1530CELEBREXCelecoxibPfizer Laboratories Div Pfizer IncNDACurrent
0025-1530CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1530CELEBREXCelecoxibG.D. Searle LLC Division of Pfizer IncNDACurrent
10544-917CelecoxibCelecoxibBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
10544-918CelecoxibCelecoxibBlenheim Pharmcal, IncNDA AUTHORIZED GENERICCurrent
10544-929CelecoxibCelecoxibBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
10544-967CelecoxibCelecoxibBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
21695-022CELEBREXCelecoxibRebel Distributors Corp.NDACurrent
21695-023CELEBREXCelecoxibRebel Distributors Corp.NDACurrent
33261-019CELEBREXCelecoxibAidarex Pharmaceuticals LLCNDACurrent
43353-036CelecoxibCelecoxibAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
45865-840CelecoxibCelecoxibMedsource PharmaceuticalsNDA AUTHORIZED GENERICCurrent
45865-840CelecoxibCelecoxibMedsource PharmaceuticalsNDA AUTHORIZED GENERICCurrent
49999-383CELEBREXCelecoxibLake Erie Medical DBA Quality Care Products LLCNDACurrent
50436-7701CelecoxibCelecoxibUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
50436-7901CelecoxibCelecoxibUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
52959-539CELEBREXCelecoxibH.J. Harkins Company, Inc.NDACurrent
52959-540CELEBREXCelecoxibH.J. Harkins Company, Inc.NDACurrent
53217-156CelecoxibCelecoxibAidarex Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
53217-157CelecoxibCelecoxibAidarex Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
55154-3621CELEBREXCelecoxibCardinal HealthNDACurrent
55154-3622CELEBREXCelecoxibCardinal HealthNDACurrent
55154-3625CELEBREXCelecoxibCardinal HealthNDACurrent
55289-451CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-451CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-451CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-451CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-451CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-451CELEBREXCelecoxibPD-Rx Pharmaceuticals, InNDACurrent
55289-475CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-475CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-475CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-475CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-475CELEBREXCelecoxibPD-Rx Pharmaceuticals, Inc.NDACurrent
59762-1515CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1515CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1515CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1516CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1516CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1516CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1517CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1517CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1517CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1518CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1518CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1518CelecoxibCelecoxibGreenstone LLCNDA AUTHORIZED GENERICCurrent
61919-045CELECOXIBCELECOXIBDIRECT RXNDACurrent
61919-046CELEBREXCELEBREXDirect RxNDACurrent
61919-046CELEBREXCELEBREXDirect RxNDACurrent
61919-168CELECOXIBCELECOXIBDirectRXNDA AUTHORIZED GENERICCurrent
63187-079CELEBREXCELECOXIBProficient Rx LPNDACurrent
63187-079CELEBREXCELECOXIBProficient Rx LPNDACurrent
63187-331CelecoxibCelecoxibProficient Rx LPANDACurrent
63629-3021CELEBREXCelecoxibBryant Ranch PrepackNDACurrent
63629-3021CELEBREXCelecoxibBryant Ranch PrepackNDACurrent
63629-3021CELEBREXCelecoxibBryant Ranch PrepackNDACurrent
63629-5503CelecoxibCelecoxibBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-5504CelecoxibCelecoxibBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6368CELEBREXCelecoxibBryant Ranch PrepackNDACurrent
66336-940CELEBREXCELECOXIBDispensing Solutions, Inc.NDACurrent
67544-204CELEBREXCelecoxibAphena Pharma Solutions - Tennessee, LLCNDACurrent
68387-552CELEBREXCelecoxibKeltman Pharmaceuticals Inc.NDACurrent
68788-0768CELEBREXCelecoxibPreferred Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80383SUPPL 2024-11-25
80382SUPPL 2024-11-25
80285SUPPL 2024-11-22
67327SUPPL2021-05-03
67326SUPPL2021-05-03
67265SUPPL2021-04-30
58577SUPPL2019-05-06
58576SUPPL2019-05-06
58569SUPPL2019-05-06
54831SUPPL2018-07-06
54721SUPPL2018-06-28
35847SUPPL2016-05-11
26448SUPPL2016-05-11
4002SUPPL2016-05-11
26447SUPPL2011-02-09
14136SUPPL2011-02-09
21344SUPPL2009-06-29
26446SUPPL2009-01-06
14135SUPPL2009-01-06
26445SUPPL2008-01-18
14134SUPPL2008-01-18
26444SUPPL2007-11-08
41867SUPPL2007-07-18
21341SUPPL2007-07-18
21339SUPPL2007-07-18
21338SUPPL2007-07-18
26443SUPPL2007-06-07
35846SUPPL2007-06-04
26442SUPPL2006-12-28
14133SUPPL2006-12-26
21345SUPPL2006-05-30
35845SUPPL2005-08-03
26441SUPPL2005-08-03
26440SUPPL2005-08-03
14132SUPPL2005-08-03
35844SUPPL2005-02-17
4001SUPPL2005-02-17
21343SUPPL2005-02-08
21342SUPPL2005-02-02
26436SUPPL2004-05-28
21340SUPPL2004-05-28
14128SUPPL2004-05-28
14131SUPPL2004-01-15
4000SUPPL2004-01-14
44085ORIG2003-12-09
26439SUPPL2002-08-29
41868SUPPL2002-06-07
26437SUPPL2002-06-07
14129SUPPL2002-06-07
26438SUPPL2001-10-18
14130SUPPL2001-10-18
41866ORIG1998-12-31
26435ORIG1998-12-31
14127ORIG1998-12-31
51815SUPPL1900-01-01
51814SUPPL1900-01-01
51813SUPPL1900-01-01
51812SUPPL1900-01-01
51811SUPPL1900-01-01
51810SUPPL1900-01-01
51809SUPPL1900-01-01
51808SUPPL1900-01-01
51807SUPPL1900-01-01