FDA.reportPublic FDA data

Application 077864

Type
ANDA
Sponsor
HIKMA PHARMS

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
0143-9580Sertraline Hydrochloridesertraline hydrochlorideWest-ward Pharmaceutical CorpANDACurrent
0143-9581Sertraline Hydrochloridesertraline hydrochlorideWest-ward Pharmaceutical CorpANDACurrent
0143-9582Sertraline Hydrochloridesertraline hydrochlorideWest-ward Pharmaceutical CorpANDACurrent
0143-9654Sertralinesertraline hydrochlorideWest-Ward Pharmaceutical CorpANDACurrent
0143-9654Sertralinesertraline hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9655Sertralinesertraline hydrochlorideWest-Ward Pharmaceutical CorpANDACurrent
0143-9655Sertralinesertraline hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9655Sertralinesertraline hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9656Sertralinesertraline hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9656Sertralinesertraline hydrochlorideWest-Ward Pharmaceutical CorpANDACurrent
51138-586Sertraline Hydrochloridesertraline hydrochlorideMed-Health Pharma, LLCANDACurrent
51138-587Sertraline Hydrochloridesertraline hydrochlorideMed-Health Pharma, LLCANDACurrent
59115-053Sertraline Hydrochloridesertraline hydrochlorideHikma PharmaceuticalANDACurrent
59115-053Sertraline Hydrochloridesertraline hydrochlorideHikma PharmaceuticalANDACurrent
59115-054Sertraline Hydrochloridesertraline hydrochlorideHikma PharmaceuticalANDACurrent
59115-054Sertraline Hydrochloridesertraline hydrochlorideHikma PharmaceuticalANDACurrent
59115-055Sertraline Hydrochloridesertraline hydrochlorideHikma PharmaceuticalANDACurrent
59115-055Sertraline Hydrochloridesertraline hydrochlorideHikma PharmaceuticalANDACurrent
64205-965Sertralinesertraline hydrochlorideReadyMedsANDACurrent