FDA.reportPublic FDA data

Application 075366

Type
ANDA
Sponsor
UPSHER SMITH LABS

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
0185-0170sotalol hydrochloridesotalol hydrochlorideEon Labs, Inc.ANDACurrent
0185-0171sotalol hydrochloridesotalol hydrochlorideEon Labs, Inc.ANDACurrent
0185-0174sotalol hydrochloridesotalol hydrochlorideEon Labs, Inc.ANDACurrent
0185-0177sotalol hydrochloridesotalol hydrochlorideEon Labs, Inc.ANDACurrent
21695-397sotalol hydrochloridesotalol hydrochlorideRebel Distributors CorpANDACurrent
43063-133sotalol hydrochloridesotalol hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30862ORIG2004-06-18
39481ORIG2004-06-17
42985ORIG2001-12-18
8634ORIG2000-05-01