FDA.reportPublic FDA data

Application 079195

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION50MG/5ML (10MG/ML)NoYes
002ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION100MG/10ML (10MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3220Rocuronium BromideRocuronium BromideSandoz IncANDACurrent
0781-3220Rocuronium BromideRocuronium BromideSandoz IncANDACurrent
0781-3220Rocuronium BromideRocuronium BromideSandoz IncANDACurrent
0781-3220Rocuronium BromideRocuronium BromideSandoz IncANDACurrent
0781-3220Rocuronium BromideRocuronium BromideSandoz IncANDACurrent
0781-3220Rocuronium BromideRocuronium BromideSandoz IncANDACurrent