FDA.reportPublic FDA data

Application 075240

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEINJECTABLE;INJECTION5MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2267Labetalol HydrochlorideLabetalol HydrochlorideHospira, Inc.ANDACurrent
0409-2267Labetalol HydrochlorideLabetalol HydrochlorideHospira, Inc.ANDACurrent
0409-2267Labetalol HydrochlorideLabetalol HydrochlorideHospira, Inc.ANDACurrent
0409-2267Labetalol HydrochlorideLabetalol HydrochlorideHospira, Inc.ANDACurrent
0409-2267Labetalol HydrochlorideLabetalol HydrochlorideHospira, Inc.ANDACurrent
0409-2267Labetalol HydrochlorideLabetalol HydrochlorideHospira, Inc.ANDACurrent
0409-2267Labetalol HydrochlorideLabetalol HydrochlorideHospira, Inc.ANDACurrent
0409-2267Labetalol HydrochlorideLabetalol HydrochlorideHospira, Inc.ANDACurrent
51662-1228LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1228LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1228LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30810ORIG2004-06-08
30809ORIG2004-06-08