FDA.reportPublic FDA data

Application 021875

Type
NDA
Sponsor
CEPHALON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUVIGILARMODAFINILTABLET;ORAL50MGYesNo
002NUVIGILARMODAFINILTABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003NUVIGILARMODAFINILTABLET;ORAL150MGYesNo
004NUVIGILARMODAFINILTABLET;ORAL250MGYesYes
005NUVIGILARMODAFINILTABLET;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3090ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3090ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3090ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3090ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3090ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3090ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3090ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3092ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3092ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3092ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3092ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3092ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3092ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3092ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3093ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3093ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3093ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3093ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3093ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3093ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3093ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3094ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3094ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3094ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3094ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3094ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3094ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3094ArmodafinilArmodafinilTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0591-3856ArmodafinilArmodafinilActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3856ArmodafinilArmodafinilActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0781-8029ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8029ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8029ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8029ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8029ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8029ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8037ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8037ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8037ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8037ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8037ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8037ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8045ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8045ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8045ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8045ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8045ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8045ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8053ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8053ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8053ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8053ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8053ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
0781-8053ArmodafinilArmodafinilSandoz IncNDA AUTHORIZED GENERICCurrent
35356-588NuvigilArmodafinilLake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-589NuvigilarmodafinilLake Erie Medical DBA Quality Care Products LLCNDACurrent
42254-014NuvigilarmodafinilRebel Distributors CorpNDACurrent
55700-510ArmodafinilArmodafinilLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
55700-510ArmodafinilArmodafinilQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
55700-510ArmodafinilArmodafinilLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
55700-510ArmodafinilArmodafinilLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
59651-047ARMODAFINILARMODAFINILAUROBINDO PHARMA LIMITEDNDACurrent
59651-047ARMODAFINILARMODAFINILAUROBINDO PHARMA LIMITEDNDACurrent
59651-047ARMODAFINILARMODAFINILAUROBINDO PHARMA LIMITEDNDACurrent
59651-047ARMODAFINILARMODAFINILAUROBINDO PHARMA LIMITEDNDACurrent
59651-047ARMODAFINILARMODAFINILAUROBINDO PHARMA LIMITEDNDACurrent
59651-047ARMODAFINILARMODAFINILAUROBINDO PHARMA LIMITEDNDACurrent
59651-047ARMODAFINILARMODAFINILAUROBINDO PHARMA LIMITEDNDACurrent
61919-562ARMODAFINILARMODAFINILDirect_RxNDA AUTHORIZED GENERICCurrent
63459-205NuvigilArmodafinilCephalon, Inc.NDACurrent
63459-205NuvigilArmodafinilCephalon, Inc.NDACurrent
63459-205NuvigilArmodafinilCephalon, Inc.NDACurrent
63459-205NuvigilArmodafinilCephalon, Inc.NDACurrent
63459-205NuvigilArmodafinilCephalon, LLCNDACurrent
63459-205NuvigilArmodafinilCephalon, LLCNDACurrent
63459-205NuvigilArmodafinilCephalon, Inc.NDACurrent
63459-205NuvigilArmodafinilCephalon, Inc.NDACurrent
63459-205NuvigilArmodafinilCephalon, Inc.NDACurrent
63459-215NuvigilArmodafinilCephalon, Inc.NDACurrent
63459-215NuvigilArmodafinilCephalon, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47154SUPPL2017-02-09
47134SUPPL2017-02-07
6358SUPPL2015-04-17
16501SUPPL2015-04-16
23307ORIG2013-07-26
37802SUPPL2013-07-15
6356SUPPL2013-07-02
28755SUPPL2012-01-19
6357SUPPL2012-01-19
28754SUPPL2010-10-25
28753SUPPL2010-10-25
28751SUPPL2010-10-25
16500SUPPL2010-10-25
16499SUPPL2010-10-25
16498SUPPL2010-10-25
28752SUPPL2009-04-01
21852ORIG2009-03-05
28750ORIG2007-07-05
37801ORIG2007-06-27