FDA.reportPublic FDA data

Application 208905

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/ML (10MG/ML)NoNo
002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)NoNo
003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9226Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9226Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9226Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9227Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9227Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9227Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9228Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9228Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9228Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent