FDA.reportPublic FDA data

Application 076051

Type
ANDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEINJECTABLE;INJECTION5MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
36000-320Labetalol HydrochlorideLabetalol HydrochlorideBaxter Healthcare CorporationANDACurrent
36000-320Labetalol HydrochlorideLabetalol HydrochlorideBaxter Healthcare CorporationANDACurrent
36000-322Labetalol HydrochlorideLabetalol HydrochlorideBaxter Healthcare CorporationANDACurrent
36000-322Labetalol HydrochlorideLabetalol HydrochlorideBaxter Healthcare CorporationANDACurrent
36000-324Labetalol HydrochlorideLabetalol HydrochlorideBaxter Healthcare CorporationANDACurrent
36000-324Labetalol HydrochlorideLabetalol HydrochlorideBaxter Healthcare CorporationANDACurrent