FDA.reportPublic FDA data

Application 075113

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL100MGNoNo
002LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL200MGNoYes
003LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0010Labetalol HClLabetalol HClEon Labs, Inc.ANDACurrent
0185-0010Labetalol HClLabetalol HClEon Labs, Inc.ANDACurrent
0185-0117Labetalol HClLabetalol HClEon Labs, Inc.ANDACurrent
0185-0117Labetalol HClLabetalol HClEon Labs, Inc.ANDACurrent
0185-0118Labetalol HClLabetalol HClEon Labs, Inc.ANDACurrent
0185-0118Labetalol HClLabetalol HClEon Labs, Inc.ANDACurrent
51079-928Labetalol HClLabetalol HClMylan Institutional Inc.ANDACurrent
51079-929Labetalol HClLabetalol HClMylan Institutional Inc.ANDACurrent
55154-5485Labetalol HClLabetalol HClCardinal HealthANDACurrent
55154-5485Labetalol HClLabetalol HClCardinal HealthANDACurrent
60687-114Labetalol HClLabetalol HClAmerican Health PackagingANDACurrent
60687-114Labetalol HClLabetalol HClAmerican Health PackagingANDACurrent
60687-125Labetalol HClLabetalol HClAmerican Health PackagingANDACurrent
60687-125Labetalol HClLabetalol HClAmerican Health PackagingANDACurrent
60687-136Labetalol HClLabetalol HClAmerican Health PackagingANDACurrent
60687-136Labetalol HClLabetalol HClAmerican Health PackagingANDACurrent
60760-610Labetalol HClLabetalol HClSt. Mary's Medical Park PharmacyANDACurrent
63739-366Labetalol HClLabetalol HClMcKesson Corporation dba SKY PackagingANDACurrent
63739-366Labetalol HClLabetalol HClMcKesson CorporationANDACurrent
63739-366Labetalol HClLabetalol HClMcKesson Corporation dba SKY PackagingANDACurrent
68001-204Labetalol HClLabetalol HClBluePoint LaboratoriesANDACurrent
68001-204Labetalol HClLabetalol HClBluePoint LaboratoriesANDACurrent
68001-205Labetalol HClLabetalol HClBluePoint LaboratoriesANDACurrent
68001-205Labetalol HClLabetalol HClBluePoint LaboratoriesANDACurrent
68001-206Labetalol HClLabetalol HClBluePoint LaboratoriesANDACurrent
68001-206Labetalol HClLabetalol HClBluePoint LaboratoriesANDACurrent
70518-0534Labetalol HClLabetalol HClREMEDYREPACK INC.ANDACurrent
70518-0534Labetalol HClLabetalol HClREMEDYREPACK INC.ANDACurrent
71335-0696Labetalol HClLabetalol HClBryant Ranch PrepackANDACurrent
71335-0696Labetalol HClLabetalol HClBryant Ranch PrepackANDACurrent
71335-0733Labetalol HClLabetalol HClBryant Ranch PrepackANDACurrent
71335-0733Labetalol HClLabetalol HClBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30759ORIG1998-08-04