FDA.reportPublic FDA data

Application 211325

Type
ANDA
Sponsor
CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL100MGNoNo
002LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL200MGNoNo
003LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71209-083Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-083Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-083Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-083Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-084Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-084Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-084Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-084Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-085Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-085Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-085Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-085Labetalol HydrochlorideLabetalol HydrochlorideCadila Pharmaceuticals LimitedANDACurrent