FDA.reportPublic FDA data

Application 214533

Type
ANDA
Sponsor
CAPLIN

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
25021-317labetalol hydrochloridelabetalol hydrochlorideSagent PharmaceuticalsANDACurrent
25021-317labetalol hydrochloridelabetalol hydrochlorideSagent PharmaceuticalsANDACurrent
65145-124Labetalol HydrochlorideLabetalol HydrochlorideCaplin Steriles LimitedANDACurrent
65145-125Labetalol HydrochlorideLabetalol HydrochlorideCaplin Steriles LimitedANDACurrent