FDA.reportPublic FDA data

Application 022187

Type
NDA
Sponsor
JANSSEN R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INTELENCEETRAVIRINETABLET;ORAL100MGYesNo
002INTELENCEETRAVIRINETABLET;ORAL200MGYesYes
003INTELENCEETRAVIRINETABLET;ORAL25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53808-0787IntelenceEtravirineState of Florida DOH Central PharmacyNDACurrent
59676-570IntelenceetravirineJanssen Products LPNDACurrent
59676-570IntelenceetravirineJanssen Products LPNDACurrent
59676-570IntelenceetravirineJanssen Products LPNDACurrent
59676-570IntelenceetravirineJanssen Products LPNDACurrent
59676-570IntelenceetravirineJanssen Products LPNDACurrent
59676-571IntelenceetravirineJanssen Products LPNDACurrent
59676-571IntelenceetravirineJanssen Products LPNDACurrent
59676-571IntelenceetravirineJanssen Products LPNDACurrent
59676-571IntelenceetravirineJanssen Products LPNDACurrent
59676-571IntelenceetravirineJanssen Products LPNDACurrent
59676-572IntelenceetravirineJanssen Products LPNDACurrent
59676-572IntelenceetravirineJanssen Products LPNDACurrent
59676-572IntelenceetravirineJanssen Products LPNDACurrent
59676-572IntelenceetravirineJanssen Products LPNDACurrent
59676-572IntelenceetravirineJanssen Products LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63916ORIG2020-07-15
59557SUPPL2019-08-02
59312SUPPL2019-07-11
56460SUPPL2018-11-15
56382SUPPL2018-11-08
54952SUPPL2018-07-23
54910SUPPL2018-07-18
38358SUPPL2014-08-22
7015SUPPL2014-08-21
29380SUPPL2013-03-01
29379SUPPL2013-03-01
17059SUPPL2013-03-01
17058SUPPL2013-03-01
17057SUPPL2013-03-01
7014SUPPL2013-03-01
29378SUPPL2012-08-15
17056SUPPL2012-08-15
7013SUPPL2012-03-28
17055SUPPL2012-03-26
38357SUPPL2011-10-12
29377SUPPL2011-10-12
29376SUPPL2010-12-28
38356SUPPL2010-12-26
17054SUPPL2010-12-22
7012SUPPL2010-12-22
38355SUPPL2010-03-03
29375SUPPL2010-03-03
38353SUPPL2009-12-02
29374SUPPL2009-11-10
38354SUPPL2009-10-06
44697ORIG2008-07-22
42441ORIG2008-03-17
38352ORIG2008-01-23
29373ORIG2008-01-23
63915ORIG1900-01-01
63914ORIG1900-01-01
63913ORIG1900-01-01
63912ORIG1900-01-01
62997SUPPL1900-01-01
62996SUPPL1900-01-01
53271ORIG1900-01-01
53270ORIG1900-01-01