FDA.reportPublic FDA data

Application 008762

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILANTIN-125PHENYTOINSUSPENSION;ORAL125MG/5MLYesYes
002DILANTIN-30PHENYTOINSUSPENSION;ORAL30MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-2214Dilantin-125PhenytoinParke-Davis Div of Pfizer IncNDACurrent
0071-2214Dilantin-125PhenytoinParke-Davis Div of Pfizer IncNDACurrent
0071-2214Dilantin-125PhenytoinParke-Davis Div of PfizerNDACurrent
0071-2214Dilantin-125PhenytoinParke-Davis Div of Pfizer IncNDACurrent
0071-2214Dilantin-125PhenytoinParke-Davis Div of Pfizer IncNDACurrent
0071-2214Dilantin-125PhenytoinParke-Davis Div of Pfizer IncNDACurrent
0071-2214Dilantin-125PhenytoinParke-Davis Div of Pfizer IncNDACurrent
59762-0531PhenytoinPhenytoinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0531PhenytoinPhenytoinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0531PhenytoinPhenytoinGreenstone LLCNDA AUTHORIZED Current
59762-0531PhenytoinPhenytoinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0531PhenytoinPhenytoinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0531PhenytoinPhenytoinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0531PhenytoinPhenytoinGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70405SUPPL2022-03-07
70404SUPPL2022-03-07
70402SUPPL2022-03-07
66277SUPPL2021-02-18
66249SUPPL2021-02-17
59337SUPPL2019-07-16
59334SUPPL2019-07-15
56060SUPPL2018-10-23
56044SUPPL2018-10-19
50313SUPPL2017-11-06
50312SUPPL2017-11-06
50254SUPPL2017-11-01
50253SUPPL2017-11-01
50252SUPPL2017-11-01
50251SUPPL2017-11-01
49566SUPPL2017-08-29
49452SUPPL2017-08-17
46056SUPPL2016-12-06
46055SUPPL2016-12-06
45992SUPPL2016-12-01
45991SUPPL2016-12-01
32977SUPPL2016-06-21
32976SUPPL2016-01-26
167SUPPL2016-01-26
113SUPPL2015-04-17
32975SUPPL2015-04-16
32974SUPPL2014-04-04
112SUPPL2014-04-04
10709SUPPL2014-01-28
166SUPPL2014-01-28
10708SUPPL2013-03-08
111SUPPL2013-03-08
40654SUPPL2012-06-26
32973SUPPL2011-12-14
32972SUPPL2011-12-14
32971SUPPL2011-12-14
32969SUPPL2011-12-14
10707SUPPL2011-12-14
165SUPPL2011-12-01
164SUPPL2011-12-01
109SUPPL2011-12-01
108SUPPL2011-12-01
106SUPPL2011-12-01
110SUPPL2011-05-31
10706SUPPL2011-01-25
107SUPPL2011-01-24
163SUPPL2009-04-29
32970SUPPL2009-04-28
162SUPPL2003-03-26
161SUPPL2001-11-20
160SUPPL2001-11-20
105SUPPL2001-11-20
104SUPPL2001-11-20