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Application 021183

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIDEX ECDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL125MGYesNo
002VIDEX ECDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL200MGYesNo
003VIDEX ECDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL250MGYesNo
004VIDEX ECDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL400MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0087-6671VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6671VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6671VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6672VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6672VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6672VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6673VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6673VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6673VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6674VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6674VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent
0087-6674VIDEX ECdidanosineBristol-Myers Squibb CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56915SUPPL2018-12-21
56770SUPPL2018-12-18
56769SUPPL2018-12-18
52103SUPPL2018-01-30
52079SUPPL2018-01-25
14603SUPPL2011-11-22
4594SUPPL2011-11-22
4593SUPPL2011-05-12
44103ORIG2010-08-09
4592SUPPL2010-02-01
14602SUPPL2010-01-29
14601SUPPL2009-06-22
27019SUPPL2009-06-16
36312SUPPL2008-10-03
4591SUPPL2008-10-02
21496SUPPL2007-07-09
4590SUPPL2006-12-28
14600SUPPL2006-12-04
27018SUPPL2006-09-18
36311SUPPL2006-08-21
42008SUPPL2005-04-08
4584ORIG2004-06-30
21495ORIG2004-03-11
36310SUPPL2004-01-22
4589SUPPL2004-01-22
27017SUPPL2003-03-10
14599SUPPL2003-03-07
36309SUPPL2002-09-26
27016SUPPL2002-09-26
14598SUPPL2002-09-26
4588SUPPL2002-09-26
14597SUPPL2002-08-05
4587SUPPL2002-08-05
36308SUPPL2002-04-01
27015SUPPL2002-04-01
4586SUPPL2002-01-29
4585SUPPL2002-01-28
36307ORIG2000-10-31
53231SUPPL1900-01-01
53230SUPPL1900-01-01