FDA.reportPublic FDA data

Application 075215

Type
ANDA
Sponsor
INNOGENIX

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
10135-641LabetalolLabetalolMarlex Pharmaceuticals IncANDACurrent
10135-642LabetalolLabetalolMarlex Pharmaceuticals IncANDACurrent
10135-643LabetalolLabetalolMarlex Pharmaceuticals IncANDACurrent
10135-711Labetalol HydrochlorideLabetalolMarlex Pharmaceuticals IncANDACurrent
10135-711Labetalol HydrochlorideLabetalolMarlex Pharmaceuticals IncANDACurrent
10135-712Labetalol HydrochlorideLabetalolMarlex Pharmaceuticals IncANDACurrent
10135-712Labetalol HydrochlorideLabetalolMarlex Pharmaceuticals IncANDACurrent
10135-713Labetalol HydrochlorideLabetalolMarlex Pharmaceuticals IncANDACurrent
10135-713Labetalol HydrochlorideLabetalolMarlex Pharmaceuticals IncANDACurrent
58657-602Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-602Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-602Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-603Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-603Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-603Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-604Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-604Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-604Labetalol HydrochlorideLabetalol HydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-605Labetalol HydrochlorideLabetalolMethod Pharmaceuticals, LLCANDACurrent
58657-606Labetalol HydrochlorideLabetalolMethod Pharmaceuticals, LLCANDACurrent
58657-607Labetalol HydrochlorideLabetalolMethod Pharmaceuticals, LLCANDACurrent
63629-1161Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1161Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1161Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1162Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1162Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1162Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1163Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1163Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1163Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1164Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1164Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1164Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1164Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1165Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1165Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1165Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1166Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1166Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-1166Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-2450Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-9283Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
63629-9300Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent
69292-501Labetalol HydrochlorideLabetalol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-502Labetalol HydrochlorideLabetalol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-503Labetalol HydrochlorideLabetalol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
71247-126Labetalol HydrochlorideLabetalol HydrochlorideInnogenix, Inc.ANDACurrent
71247-126Labetalol HydrochlorideLabetalol HydrochlorideInnogenix, Inc.ANDACurrent
71247-127Labetalol HydrochlorideLabetalol HydrochlorideInnogenix, Inc.ANDACurrent
71247-127Labetalol HydrochlorideLabetalol HydrochlorideInnogenix, Inc.ANDACurrent
71247-130Labetalol HydrochlorideLabetalol HydrochlorideInnogenix, Inc.ANDACurrent
71247-130Labetalol HydrochlorideLabetalol HydrochlorideInnogenix, Inc.ANDACurrent
71335-2057Labetalol HydrochlorideLabetalol HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30797ORIG1999-07-29