FDA.reportPublic FDA data

Application 103949

Type
BLA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEGINTRONPEGINTERFERON ALFA-2BVIAL50UG/0.5MLNoNo
002PEGINTRONPEGINTERFERON ALFA-2BVIAL80UG/0.5MLNoNo
003PEGINTRONPEGINTERFERON ALFA-2BVIAL120UG/0.5MLNoNo
004PEGINTRONPEGINTERFERON ALFA-2BVIAL150UG/0.5MLNoNo
005PEGINTRONPEGINTERFERON ALFA-2BSYRINGE50UG/0.5MLNoNo
006PEGINTRONPEGINTERFERON ALFA-2BSYRINGE80UG/0.5MLNoNo
007PEGINTRONPEGINTERFERON ALFA-2BSYRINGE150UG/0.5MLNoNo
008PEGINTRONPEGINTERFERON ALFA-2BSYRINGE120UG/0.5MLNoNo
009SYLATRONPEGINTERFERON ALFA-2BVIAL296 MCG LYOPHILIZED POWDER PER SINGLE-USE VIALNoNo
010SYLATRONPEGINTERFERON ALFA-2BVIAL444 MCG LYOPHILIZED POWDER PER SINGLE-USE VIALNoNo
011SYLATRONPEGINTERFERON ALFA-2BVIAL888 MCG LYOPHILIZED POWDER PER SINGLE-USE VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1297PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1297PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1297PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1316PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1316PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1316PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1323PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1323PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1323PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1370PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1370PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-1370PEGINTRONPeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4347SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4347SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4347SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4348SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4348SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4348SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4349SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4349SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4349SYLATRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4353PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4353PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4353PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4354PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4354PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4354PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4355PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4355PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4355PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4356PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4356PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent
0085-4356PEGINTRONpeginterferon alfa-2bMerck Sharp & Dohme Corp.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59613SUPPL2019-08-07
57330SUPPL2019-01-23
57156SUPPL2019-01-09
57155SUPPL2019-01-09
57088SUPPL2018-12-31
57007SUPPL2018-12-26
57006SUPPL2018-12-26
54363SUPPL2018-05-29
54362SUPPL2018-05-29
54360SUPPL2018-05-29
54012SUPPL2018-05-04
53998SUPPL2018-05-03
49960SUPPL2017-10-05
49955SUPPL2017-10-05
49947SUPPL2017-10-04
49946SUPPL2017-10-04
49939SUPPL2017-10-04
49938SUPPL2017-10-04
48553SUPPL2017-05-30
48552SUPPL2017-05-26
18692SUPPL2015-09-23
31723SUPPL2015-09-17
18690SUPPL2015-05-27
31722SUPPL2015-05-22
9506SUPPL2015-05-19
18691SUPPL2015-05-14
18688SUPPL2014-11-20
31719SUPPL2014-11-19
31721SUPPL2014-10-10
9505SUPPL2014-09-08
39749SUPPL2014-09-03
39748SUPPL2014-08-15
31717SUPPL2014-08-15
31718SUPPL2014-08-12
18687SUPPL2014-08-12
31720SUPPL2014-08-01
18689SUPPL2014-08-01
31715SUPPL2013-12-20
18684SUPPL2013-12-19
9504SUPPL2013-11-25
18686SUPPL2013-11-22
18685SUPPL2013-05-21
31716SUPPL2013-05-16
39747SUPPL2012-12-28
9503SUPPL2012-12-28
31714SUPPL2012-07-09
18683SUPPL2012-07-06
9502SUPPL2012-06-07
31713SUPPL2011-12-28
31712SUPPL2011-12-28
18682SUPPL2011-12-23
18681SUPPL2011-12-23
9501SUPPL2011-12-13
18680SUPPL2011-12-07
39746SUPPL2011-03-31
9500SUPPL2011-03-31
31711SUPPL2011-02-15
31710SUPPL2009-06-10
31708SUPPL2009-06-08
18678SUPPL2009-06-07
9499SUPPL2009-03-23
39745SUPPL2009-03-19
18679SUPPL2009-01-16
18677SUPPL2009-01-16
31709SUPPL2008-12-24
31707SUPPL2008-12-24
39744SUPPL2007-01-16
31706SUPPL2007-01-16
22761SUPPL2005-12-08
39742SUPPL2005-11-18
31703SUPPL2005-11-03
39743SUPPL2005-08-08
31705SUPPL2005-08-08
31704SUPPL2005-01-26
18676SUPPL2005-01-26
39741SUPPL2004-03-25
39740ORIG2004-03-25
22760ORIG2004-03-25
9498SUPPL2004-03-25
9497ORIG2004-03-25
63539SUPPL1900-01-01
63538SUPPL1900-01-01