FDA.reportPublic FDA data

Application 077106

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 25MG BASENoNo
002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-043Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
65841-043Sertraline HydrochlorideSertraline HydrochlorideZydus Lifesciences LimitedANDACurrent
65841-043Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
65841-043Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
65841-044Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
65841-044Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
65841-044Sertraline HydrochlorideSertraline HydrochlorideZydus Lifesciences LimitedANDACurrent
65841-044Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
65841-045Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
65841-045Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
65841-045Sertraline HydrochlorideSertraline HydrochlorideZydus Lifesciences LimitedANDACurrent
65841-045Sertraline HydrochlorideSertraline HydrochlorideCadila Healthcare LimitedANDACurrent
68382-043Sertraline HydrochlorideSertraline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-043Sertraline HydrochlorideSertraline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-044Sertraline HydrochlorideSertraline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-044Sertraline HydrochlorideSertraline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-045Sertraline HydrochlorideSertraline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-045Sertraline HydrochlorideSertraline HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent