FDA.reportPublic FDA data

Application 214790

Type
ANDA
Sponsor
ASCENT PHARMS INC

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
31722-145SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-145SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-145SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-146SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-146SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-146SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-147SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-147SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-147SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
43602-462SERTRALINE HYDROCHLORIDEsertraline hydrochlorideAscent Pharmaceuticals, IncANDACurrent
43602-463SERTRALINE HYDROCHLORIDEsertraline hydrochlorideAscent Pharmaceuticals, IncANDACurrent
43602-464SERTRALINE HYDROCHLORIDEsertraline hydrochlorideAscent Pharmaceuticals, IncANDACurrent
43602-979SERTRALINE HYDROCHLORIDEsertraline hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-980SERTRALINE HYDROCHLORIDEsertraline hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-981SERTRALINE HYDROCHLORIDEsertraline hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
72865-205SERTRALINE HYDROCHLORIDEsertraline hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-205SERTRALINE HYDROCHLORIDEsertraline hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-206SERTRALINE HYDROCHLORIDEsertraline hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-206SERTRALINE HYDROCHLORIDEsertraline hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-207SERTRALINE HYDROCHLORIDEsertraline hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-207SERTRALINE HYDROCHLORIDEsertraline hydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent