FDA.reportPublic FDA data

Application 075429

Type
ANDA
Sponsor
TEVA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1060Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1060Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1060Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1060Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1061Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1061Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1061Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1061Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1062Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1062Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1062Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1062Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1063Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1063Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1063Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1063Sotalol HydrochlorideSotalol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
71205-046Sotalol HydrochlorideSotalol HydrochlorideProficient Rx LPANDACurrent
71205-046Sotalol HydrochlorideSotalol HydrochlorideProficient Rx LPANDACurrent
71205-046Sotalol HydrochlorideSotalol HydrochlorideProficient Rx LPANDACurrent
71335-0860Sotalol HydrochlorideSotalol HydrochlorideBryant Ranch PrepackANDACurrent
71335-0860Sotalol HydrochlorideSotalol HydrochlorideBryant Ranch PrepackANDACurrent
71335-0860Sotalol HydrochlorideSotalol HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30880ORIG2004-06-17
18410ORIG2004-06-17
42995ORIG2001-12-17
30881ORIG2000-05-01