Application 050632

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZACTAM IN PLASTIC CONTAINERAZTREONAMINJECTABLE;INJECTION40MG/MLYesNo
002AZACTAM IN PLASTIC CONTAINERAZTREONAMINJECTABLE;INJECTION20MG/MLYesNo
003AZACTAM IN PLASTIC CONTAINERAZTREONAMINJECTABLE;INJECTION10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-2230AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2240AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54676SUPPL2018-06-21
54637SUPPL2018-06-21
7912SUPPL2013-06-18
17956SUPPL2013-06-17
39057SUPPL2008-01-24
7911SUPPL2008-01-24
30196SUPPL2004-12-30
30195SUPPL2002-03-25
39056SUPPL1998-12-24
22172SUPPL1998-12-24
7910SUPPL1998-12-24