FDA.reportPublic FDA data

Application 209603

Type
ANDA
Sponsor
TWI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL100MGNoNo
002LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL200MGNoNo
003LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL300MGNoNo
004LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24979-168Labetalol HydrochlorideLabetalol HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-169Labetalol HydrochlorideLabetalol HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-170Labetalol HydrochlorideLabetalol HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
51407-614Labetalol HydrochlorideLabetalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-615Labetalol HydrochlorideLabetalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-616Labetalol HydrochlorideLabetalol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
63629-8898Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8898Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8898Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8899Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8899Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8899Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8900Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8900Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8901Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8901Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8902Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8902Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8903Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-8903Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
70377-060Labetalol HydrochlorideLabetalol HydrochlorideBiocon Pharma Inc.ANDACurrent
70377-061Labetalol HydrochlorideLabetalol HydrochlorideBiocon Pharma Inc.ANDACurrent
70377-062Labetalol HydrochlorideLabetalol HydrochlorideBiocon Pharma Inc.ANDACurrent