FDA.reportPublic FDA data

Application 020717

Type
NDA
Sponsor
CEPHALON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROVIGILMODAFINILTABLET;ORAL100MGYesNo
002PROVIGILMODAFINILTABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-234PROVIGILMODAFINILRebel Distributors CorpNDACurrent
21695-235PROVIGILMODAFINILRebel Distributors CorpNDACurrent
35356-372PROVIGILmodafinilLake Erie Medical Surgical & Supply DBA Quality Care Products LLCNDACurrent
43353-925modafinilmodafinilAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-956ModafinilModafinilAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
49884-534ModafinilModafinilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-535ModafinilModafinilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
50436-0201ProvigilModafinilUnit Dose ServicesNDACurrent
50436-0201ProvigilModafinilUnit Dose ServicesNDACurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-801ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
55253-802ModafinilModafinilCIMA LABS INC.NDA AUTHORIZED GENERICCurrent
63459-101ProvigilModafinilCephalon, LLCNDACurrent
63459-101ProvigilModafinilCephalon, Inc.NDACurrent
63459-101ProvigilModafinilCephalon, Inc.NDACurrent
63459-101ProvigilModafinilCephalon, Inc.NDACurrent
63459-101ProvigilModafinilCephalon, LLCNDACurrent
63459-101ProvigilModafinilCephalon, Inc.NDACurrent
63459-101ProvigilModafinilCephalon, Inc.NDACurrent
63459-101ProvigilModafinilCephalon, Inc.NDACurrent
63459-101ProvigilModafinilCephalon, Inc.NDACurrent
63459-201ProvigilModafinilCephalon, Inc.NDACurrent
63459-201ProvigilModafinilCephalon, Inc.NDACurrent
63459-201ProvigilModafinilCephalon, Inc.NDACurrent
63459-201ProvigilModafinilCephalon, Inc.NDACurrent
63459-201ProvigilModafinilCephalon, LLCNDACurrent
63459-201ProvigilModafinilCephalon, Inc.NDACurrent
63459-201ProvigilModafinilCephalon, Inc.NDACurrent
63459-201ProvigilModafinilCephalon, LLCNDACurrent
63459-201ProvigilModafinilCephalon, Inc.NDACurrent
68258-7981modafinilmodafinilDispensing Solutions, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
35216SUPPL2015-01-20
25626SUPPL2015-01-20
13285SUPPL2015-01-20
3192SUPPL2015-01-20
3194SUPPL2012-01-19
3193SUPPL2012-01-19
43675SUPPL2010-10-25
43674SUPPL2010-10-25
35215SUPPL2010-10-25
25625SUPPL2010-10-25
25624SUPPL2010-10-25
23180SUPPL2010-10-25
13284SUPPL2010-10-25
13283SUPPL2010-10-25
3191SUPPL2010-10-25
41612SUPPL2007-09-24
20875SUPPL2007-09-24
25623SUPPL2007-08-22
35214SUPPL2007-08-21
35213SUPPL2007-08-21
13282SUPPL2007-08-21
41611SUPPL2007-04-11
41610SUPPL2007-04-11
41609SUPPL2007-04-11
20874SUPPL2007-04-11
13281SUPPL2004-02-03
3189SUPPL2004-02-02
3190SUPPL2003-08-15
3188SUPPL2003-05-29
41608ORIG1998-12-24
25622ORIG1998-12-24
13280ORIG1998-12-24
52057ORIG1900-01-01
52056ORIG1900-01-01
52055ORIG1900-01-01
52054ORIG1900-01-01