FDA.reportPublic FDA data

Application 075500

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SORINESOTALOL HYDROCHLORIDETABLET;ORAL80MGNoNo
002SORINESOTALOL HYDROCHLORIDETABLET;ORAL160MGNoNo
003SORINESOTALOL HYDROCHLORIDETABLET;ORAL240MGNoNo
004SORINESOTALOL HYDROCHLORIDETABLET;ORAL120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0012SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0012SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0012SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0013SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0013SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0013SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0014SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0014SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0014SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0015SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0015SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
0245-0015SorineSotalol HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
55154-5616SorineSotalol HydrochlorideCardinal HealthANDACurrent
55154-5616SorineSotalol HydrochlorideCardinal HealthANDACurrent
55154-5616SorineSotalol HydrochlorideCardinal HealthANDACurrent
55154-5616SorineSotalol HydrochlorideCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30914ORIG2001-04-27