FDA.reportPublic FDA data

Application 077397

Type
ANDA
Sponsor
INVAGEN 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
0615-6558SertralineSertraline HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6559SertralineSertraline HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6560SertralineSertraline HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-164Sertraline Hydrochloridesertraline hydrochlorideRebel Distributors CorpANDACurrent
21695-165Sertraline Hydrochloridesertraline hydrochlorideRebel Distributors CorpANDACurrent
21695-166Sertraline Hydrochloridesertraline hydrochlorideRebel Distributors CorpANDACurrent
31722-212Sertraline HydrochlorideSertraline HydrochlorideCamber Pharmaceuticals Inc.ANDACurrent
31722-213Sertraline HydrochlorideSertraline HydrochlorideCamber Pharmaceuticals Inc.ANDACurrent
31722-214Sertraline HydrochlorideSertraline HydrochlorideCamber Pharmaceuticals Inc.ANDACurrent
33261-170Sertraline HydrochlorideSertraline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-171Sertraline HydrochlorideSertraline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
35356-669Sertraline HydrochlorideSertraline HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
43063-033Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-033Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-033Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-033Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-033Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-033Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-754Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
43063-754Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-754Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-754Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-754Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-754Sertraline HydrochlorideSertraline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-809SERTRALINESertralineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-809SERTRALINESertralineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-812SERTRALINESertralineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-817SERTRALINESertralineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-817SERTRALINESertralineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-970Sertraline HydrochlorideSertraline HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-370Sertraline HydrochlorideSertraline HydrochlorideMedsource PharmaceuticalsANDACurrent
45865-518Sertraline HydrochlorideSertraline HydrochlorideMedsource PharmaceuticalsANDACurrent
45865-518Sertraline HydrochlorideSertraline HydrochlorideMedsource PharmaceuticalsANDACurrent
50090-2609Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-2609Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-2779Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-2976Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-3153Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-3217Sertraline HydrochlorideSertraline HydrochlorideA-S Medication SolutionsANDACurrent
50090-3562SERTRALINESertralineA-S Medication SolutionsANDACurrent
50090-3562SERTRALINESertralineA-S Medication SolutionsANDACurrent
50090-3562SERTRALINESertralineA-S Medication SolutionsANDACurrent
50436-0834Sertraline HydrochlorideSertraline HydrochlorideUnit Dose ServicesANDACurrent
50436-0835Sertraline HydrochlorideSertraline HydrochlorideUnit Dose ServicesANDACurrent
50436-6304SERTRALINESertraline HydrochlorideUnit Dose ServicesANDACurrent
50436-6305Sertraline HydrochlorideSertraline HydrochlorideUnit Dose ServicesANDACurrent
50436-6306Sertraline HydrochlorideSertraline HydrochlorideUnit Dose ServicesANDACurrent
51138-585Sertraline Hydrochloridesertraline hydrochlorideMed-Health Pharma, LLCANDACurrent
51655-345Sertraline HydrochlorideSertraline HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-345Sertraline HydrochlorideSertraline HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-830SertralineSertralineNorthwind Pharmaceuticals, LLCANDACurrent
52959-872Sertraline HydrochlorideSertraline HydrochlorideH.J. Harkins Company Inc.ANDACurrent
52959-875Sertraline HydrochlorideSertraline HydrochlorideH.J. Harkins Company Inc.ANDACurrent
52959-876Sertraline HydrochlorideSertraline HydrochlorideH.J. Harkins Company Inc.ANDACurrent
53002-1192Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1192Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1215Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1215Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1507Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1507Sertraline HydrochlorideSertraline HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-242Sertraline HydrochlorideSertraline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53217-257Sertraline HydrochlorideSertraline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53808-0579Sertraline Hydrochloridesertraline hydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0581Sertraline Hydrochloridesertraline hydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0587Sertraline Hydrochloridesertraline hydrochlorideState of Florida DOH Central PharmacyANDACurrent
55154-4687Sertraline HydrochlorideSertraline HydrochlorideCardinal Health 107, LLCANDACurrent
55154-4687Sertraline HydrochlorideSertraline HydrochlorideCardinal HealthANDACurrent
55154-4687Sertraline HydrochlorideSertraline HydrochlorideCardinal HealthANDACurrent
55154-4687Sertraline HydrochlorideSertraline HydrochlorideCardinal HealthANDACurrent
55154-4692Sertraline HydrochlorideSertraline HydrochlorideCardinal Health 107, LLCANDACurrent
55154-4692Sertraline HydrochlorideSertraline HydrochlorideCardinal HealthANDACurrent
55154-4692Sertraline HydrochlorideSertraline HydrochlorideCardinal HealthANDACurrent
55154-4692Sertraline HydrochlorideSertraline HydrochlorideCardinal HealthANDACurrent
55154-6627SertralineSertraline HydrochlorideCardinal HealthANDACurrent
55154-6627SertralineSertraline HydrochlorideCardinal HealthANDACurrent
55154-6631SertralineSertraline HydrochlorideCardinal HealthANDACurrent
58118-0834Sertraline HydrochlorideSertraline HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0834Sertraline HydrochlorideSertraline HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0834Sertraline HydrochlorideSertraline HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
60687-231Sertraline HydrochlorideSertraline HydrochlorideAmerican Health PackagingANDACurrent