FDA.reportPublic FDA data

Application 018841

Type
NDA
Sponsor
GD SEARLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004DAYPROOXAPROZINTABLET;ORAL600MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1381DayprooxaprozinPfizer Laboratories Div Pfizer IncNDACurrent
0025-1381DayprooxaprozinG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1381DayprooxaprozinG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1381DayprooxaprozinG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1381DayprooxaprozinPfizer Laboratories Div Pfizer IncNDACurrent
0025-1381DayprooxaprozinPfizer Laboratories Div Pfizer IncNDACurrent
0025-1381DayprooxaprozinPfizer Laboratories Div Pfizer IncNDACurrent
0025-1381DayprooxaprozinPfizer Laboratories Div Pfizer IncNDACurrent
55289-453DayprooxaprozinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-453DayprooxaprozinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-453DayprooxaprozinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-453DayprooxaprozinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-453DayprooxaprozinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-453DayprooxaprozinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-453DayprooxaprozinPD-Rx Pharmaceuticals, Inc.NDACurrent
59762-6002oxaprozinoxaprozinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6002oxaprozinoxaprozinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6002oxaprozinoxaprozinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6002oxaprozinoxaprozinGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80375SUPPL 2024-11-25
80374SUPPL 2024-11-25
80278SUPPL 2024-11-22
73535SUPPL 2022-11-09
67304SUPPL2021-04-30
67303SUPPL2021-04-30
67259SUPPL2021-04-29
58582SUPPL2019-05-06
58581SUPPL2019-05-06
58563SUPPL2019-05-06
23125SUPPL2016-05-18
16070SUPPL2016-05-12
33625SUPPL2016-05-11
11351SUPPL2014-05-07
1105SUPPL2007-07-05
33624SUPPL2006-01-20
16069SUPPL2006-01-20
16068SUPPL2004-06-02
33623SUPPL2003-04-17
33622SUPPL2002-01-25
16067SUPPL2002-01-25
11350SUPPL2002-01-25
1104SUPPL2002-01-25