FDA.reportPublic FDA data

Application 074787

Type
ANDA
Sponsor
HERITAGE PHARMA

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
0615-4539Labetalol HydrochlorideLabetalol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7686Labetalol HydrochlorideLabetalol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7687Labetalol HydrochlorideLabetalol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7688Labetalol HydrochlorideLabetalol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
23155-723Labetalol HydrochlorideLabetalol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-723Labetalol HydrochlorideLabetalol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-724Labetalol HydrochlorideLabetalol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-724Labetalol HydrochlorideLabetalol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-725Labetalol HydrochlorideLabetalol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-725Labetalol HydrochlorideLabetalol HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
50436-4365Labetalol HydrochlorideLabetalol HydrochlorideUnit Dose ServicesANDACurrent
68258-6047Labetalol HydrochlorideLabetalol HydrochlorideDispensing Solutions, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39441ORIG2004-06-08
22370ORIG2003-08-01
30698ORIG1998-08-03