FDA.reportPublic FDA data

Application 075431

Type
ANDA
Sponsor
AKORN INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-420Labetalol HydrochlorideLabetalol HydrochlorideAkorn, Inc.ANDACurrent
17478-420Labetalol HydrochlorideLabetalol HydrochlorideAkorn, Inc.ANDACurrent
17478-420Labetalol HydrochlorideLabetalol HydrochlorideAkornANDACurrent
17478-420Labetalol HydrochlorideLabetalol HydrochlorideAkorn, Inc.ANDACurrent
17478-420Labetalol HydrochlorideLabetalol HydrochlorideAkornANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30883ORIG1999-12-29