FDA.reportPublic FDA data

Application 020450

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEREBYXFOSPHENYTOIN SODIUMINJECTABLE;INJECTIONEQ 50MG PHENYTOIN NA/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5471CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-5474CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6001CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6001CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6001CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6001CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6001CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6001CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6001CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent
0069-6001CEREBYXFosphenytoin SodiumPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70854SUPPL2022-04-29
69477SUPPL2021-12-06
69476SUPPL2021-12-06
66276SUPPL2021-02-18
66250SUPPL2021-02-17
61734SUPPL2020-01-29
61715SUPPL2020-01-29
59338SUPPL2019-07-16
59336SUPPL2019-07-15
50311SUPPL2017-11-06
50310SUPPL2017-11-06
50258SUPPL2017-11-01
50257SUPPL2017-11-01
47570SUPPL2017-03-16
47554SUPPL2017-03-14
47396SUPPL2017-03-02
47387SUPPL2017-03-02
45833SUPPL2016-11-08
45825SUPPL2016-11-07
34673SUPPL2016-06-21
34672SUPPL2016-03-04
2556SUPPL2016-03-04
34671SUPPL2015-06-10
24990SUPPL2015-06-10
24989SUPPL2014-06-17
12601SUPPL2014-06-17
24988SUPPL2014-01-07
12600SUPPL2014-01-07
34670SUPPL2013-11-20
2555SUPPL2013-10-24
34669SUPPL2013-03-08
24987SUPPL2013-03-08
24986SUPPL2011-11-17
24985SUPPL2011-11-17
2554SUPPL2011-11-17
2553SUPPL2011-11-17
34668SUPPL2011-11-16
34667SUPPL2011-11-16
12599SUPPL2011-11-16
12598SUPPL2011-11-16
20665SUPPL2007-05-30
41376SUPPL2007-05-29
41375SUPPL2003-06-17
34666SUPPL2003-04-25
12597SUPPL2001-08-31
57444ORIG1997-04-11
51131SUPPL1900-01-01
51130SUPPL1900-01-01
51129SUPPL1900-01-01