Application 020412

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZERITSTAVUDINECAPSULE;ORAL5MGNoNo
002ZERITSTAVUDINECAPSULE;ORAL15MGYesNo
003ZERITSTAVUDINECAPSULE;ORAL20MGYesNo
004ZERITSTAVUDINECAPSULE;ORAL30MGYesNo
005ZERITSTAVUDINECAPSULE;ORAL40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-1964ZERITStavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1965ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1965ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1965ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1966ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1966ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1966ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1967ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1967ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1967ZERITstavudineE.R. Squibb & Sons, L.L.C.NDACurrent
53808-0656ZERITstavudineState of Florida DOH Central PharmacyNDACurrent
53808-0657ZERITstavudineState of Florida DOH Central PharmacyNDACurrent
53808-0795ZERITstavudineState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56917SUPPL2018-12-21
56777SUPPL2018-12-18
56776SUPPL2018-12-18
50867SUPPL2017-12-27
50820SUPPL2017-12-21
34633SUPPL2011-11-22
24942SUPPL2011-11-22
2513SUPPL2011-05-16
2512SUPPL2010-12-28
12558SUPPL2010-12-23
2511SUPPL2009-07-15
34632SUPPL2009-07-09
34631SUPPL2009-02-20
24941SUPPL2009-02-18
34630SUPPL2009-01-02
2510SUPPL2008-12-18
34629SUPPL2008-04-23
12557SUPPL2008-04-23
2509SUPPL2008-04-16
2508SUPPL2008-04-16
2507SUPPL2007-06-14
2506SUPPL2007-04-25
34628SUPPL2007-02-05
34627SUPPL2004-06-07
2505SUPPL2004-06-07
34626SUPPL2003-04-22
12556SUPPL2002-03-29
2504SUPPL2002-03-29
24940SUPPL2002-02-20
24939SUPPL2002-02-20