FDA.reportPublic FDA data

Application 020785

Type
NDA
Sponsor
CELGENE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THALOMIDTHALIDOMIDECAPSULE;ORAL50MGYesNo
002THALOMIDTHALIDOMIDECAPSULE;ORAL100MGYesNo
003THALOMIDTHALIDOMIDECAPSULE;ORAL200MGYesYes
004THALOMIDTHALIDOMIDECAPSULE;ORAL150MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59572-205ThalomidThalidomideCelgene CorporationNDACurrent
59572-205ThalomidThalidomideCelgene CorporationNDACurrent
59572-205ThalomidThalidomideCelgene CorporationNDACurrent
59572-205ThalomidThalidomideCelgene CorporationNDACurrent
59572-205ThalomidThalidomideCelgene CorporationNDACurrent
59572-210ThalomidThalidomideCelgene CorporationNDACurrent
59572-210ThalomidThalidomideCelgene CorporationNDACurrent
59572-210ThalomidThalidomideCelgene CorporationNDACurrent
59572-210ThalomidThalidomideCelgene CorporationNDACurrent
59572-210ThalomidThalidomideCelgene CorporationNDACurrent
59572-215ThalomidThalidomideCelgene CorporationNDACurrent
59572-215ThalomidThalidomideCelgene CorporationNDACurrent
59572-215ThalomidThalidomideCelgene CorporationNDACurrent
59572-215ThalomidThalidomideCelgene CorporationNDACurrent
59572-215ThalomidThalidomideCelgene CorporationNDACurrent
59572-220ThalomidThalidomideCelgene CorporationNDACurrent
59572-220ThalomidThalidomideCelgene CorporationNDACurrent
59572-220ThalomidThalidomideCelgene CorporationNDACurrent
59572-220ThalomidThalidomideCelgene CorporationNDACurrent
59572-220ThalomidThalidomideCelgene CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85781SUPPL 2026-05-01
73881SUPPL 2023-03-27
73880SUPPL 2023-03-27
73874SUPPL 2023-03-27
68314SUPPL2021-08-06
66436SUPPL2021-03-02
66412SUPPL2021-03-01
61182SUPPL2019-12-06
61181SUPPL2019-12-06
61161SUPPL2019-12-05
59005SUPPL2019-06-10
59004SUPPL2019-06-10
59002SUPPL2019-06-10
50952SUPPL2018-01-02
50951SUPPL2018-01-02
50946SUPPL2017-12-29
50575SUPPL2017-12-01
50539SUPPL2017-12-01
48700SUPPL2017-06-12
47049SUPPL2017-01-31
47031SUPPL2017-01-27
25839SUPPL2016-04-25
25838SUPPL2015-12-02
3355SUPPL2015-10-29
3354SUPPL2015-09-15
25836SUPPL2015-08-10
35357SUPPL2015-08-07
25837SUPPL2014-09-16
35358SUPPL2014-06-23
3353SUPPL2014-06-23
3352SUPPL2013-11-18
35356SUPPL2013-02-12
3351SUPPL2013-02-12
25835SUPPL2012-02-08
25834SUPPL2012-02-08
25833SUPPL2012-02-08
35355SUPPL2012-02-06
35354SUPPL2012-02-06
13437SUPPL2012-02-06
23984ORIG2010-08-16
3350SUPPL2010-08-06
20953SUPPL2007-07-27
20952SUPPL2007-07-27
25832SUPPL2007-01-16
20951ORIG2006-09-06
13436SUPPL2006-05-26
3349SUPPL2006-05-26
25827SUPPL2004-06-18
25831SUPPL2004-03-10
25830SUPPL2004-03-10
44072ORIG2003-12-12
35353SUPPL2003-10-31
25829SUPPL2003-10-31
25828SUPPL2003-10-31
13435SUPPL2003-10-31
13434SUPPL2003-10-31
3348SUPPL2003-10-31
35351SUPPL2003-04-23
35352SUPPL2003-03-06
25826SUPPL2003-01-17
13433SUPPL2003-01-17
41700SUPPL2001-09-05
25825SUPPL2001-09-05
13432SUPPL2001-09-05
3347SUPPL2001-09-05
13431ORIG1998-07-16
3346ORIG1998-07-16