FDA.reportPublic FDA data

Application 076214

Type
ANDA
Sponsor
APOTEX

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0222Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0222Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0222Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0222Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0223Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0223Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0223Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0223Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0224Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0224Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0224Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
60505-0224Sotalol HydrochlorideSotalol HydrochlorideApotex Corp.ANDACurrent
71610-074Sotalol HydrochlorideSotalol HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent