FDA.reportPublic FDA data

Application 020156

Type
NDA
Sponsor
BRISTOL-MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIDEXDIDANOSINEFOR SOLUTION;ORAL10MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0087-6632VIDEXdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6632VIDEXdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6632VIDEXdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6633VIDEXdidanosineBristol-Myers Squibb CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56916SUPPL2018-12-21
56775SUPPL2018-12-18
56774SUPPL2018-12-18
52105SUPPL2018-01-30
51922SUPPL2018-01-26
51921SUPPL2018-01-26
12282SUPPL2014-08-12
2109SUPPL2014-08-12
34325SUPPL2011-11-22
21233SUPPL2011-11-22
2108SUPPL2011-05-12
44048ORIG2010-08-09
2107SUPPL2010-02-01
12281SUPPL2010-01-29
12280SUPPL2009-06-22
2106SUPPL2009-06-17
41181SUPPL2007-11-19
20498SUPPL2007-08-06
20497SUPPL2007-08-06
2105SUPPL2006-12-28
12279SUPPL2006-12-04
21232SUPPL2006-09-18
12278SUPPL2006-08-21
41180SUPPL2005-04-27
20501SUPPL2005-04-27
41179SUPPL2005-04-19
20500SUPPL2005-04-19
41178SUPPL2005-01-06
20499SUPPL2004-08-09
12277SUPPL2004-01-22
2104SUPPL2004-01-22
34323SUPPL2003-04-21
12273SUPPL2003-04-21
2103SUPPL2003-03-10
34324SUPPL2003-03-07
21231SUPPL2002-09-25
12276SUPPL2002-09-25
12275SUPPL2002-09-25
2102SUPPL2002-09-25
21230SUPPL2002-04-01
12274SUPPL2002-04-01
2101SUPPL1999-10-29
34322SUPPL1999-10-21