FDA.report

Application 077670

Type
ANDA
Sponsor
LUPIN

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7989SertralineSertralineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7989SertralineSertralineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7989SertralineSertralineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7990SertralineSertralineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7990SertralineSertralineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7990SertralineSertralineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7991SertralineSertralineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7991SertralineSertralineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7991SertralineSertralineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6924SertralineSertralineMajor PharmaceuticalsANDACurrent
0904-6925SertralineSertralineMajor PharmaceuticalsANDACurrent
0904-6926SertralineSertralineMajor PharmaceuticalsANDACurrent
33261-346SertralineSertralineAidarex Pharmaceuticals LLCANDACurrent
35356-832SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
42708-068SertralineSertralineQPharma IncANDACurrent
42708-068SertralineSertralineQPharma IncANDACurrent
50090-0989SertralineSertralineA-S Medication SolutionsANDACurrent
50090-0989SertralineSertralineA-S Medication SolutionsANDACurrent
50090-0991SertralineSertralineA-S Medication SolutionsANDACurrent
50090-5848SertralineSertralineA-S Medication SolutionsANDACurrent
50436-3520SertralineSertralineUnit Dose ServicesANDACurrent
51655-352SertralineSertralineNorthwind Pharmaceuticals, LLCANDACurrent
51655-979SertralineSertralineNorthwind PharmaceuticalsANDACurrent
53217-380SertralineSertralineAidarex Pharmaceuticals LLCANDACurrent
53808-0586SERTRALINE HYDROCHLORIDEsertraline hydrochlorideState of Florida DOH Central PharmacyANDACurrent
55154-3569SertralineSertralineCardinal Health 107, LLCANDACurrent
55154-3570SertralineSertralineCardinal Health 107, LLCANDACurrent
55700-222SertralineSertralineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-225SertralineSertralineQuality Care Products, LLCANDACurrent
57297-351SertralineSertralineLUPIN LIMITEDANDACurrent
57297-352SertralineSertralineLUPIN LIMITEDANDACurrent
57297-353SertralineSertralineLUPIN LIMITEDANDACurrent
63187-055SertralineSertralineProficient Rx LPANDACurrent
63187-055SertralineSertralineProficient Rx LPANDACurrent
63187-055SertralineSertralineProficient Rx LPANDACurrent
63187-212SertralineSertralineProficient Rx LPANDACurrent
63187-212SertralineSertralineProficient Rx LPANDACurrent
63187-212SertralineSertralineProficient Rx LPANDACurrent
63187-478SertralineSertralineProficient Rx LPANDACurrent
63187-478SertralineSertralineProficient Rx LPANDACurrent
63187-478SertralineSertralineProficient Rx LPANDACurrent
64725-0351SertralineSertralineTYA PharmaceuticalsANDACurrent
67046-668SertralineSertralineContract Pharmacy Services-PAANDACurrent
67296-1199SertralineSertralineRedPharm Drug, Inc.ANDACurrent
67296-1199SertralineSertralineRedPharm Drug, Inc.ANDACurrent
67296-1199SertralineSertralineRedPharm Drug, Inc.ANDACurrent
68071-4400SertralineSertralineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4400SertralineSertralineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4400SertralineSertralineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4400SertralineSertralineNuCare Pharmaceuticals,Inc.ANDACurrent
68180-351SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-351SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-351SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-351SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-351SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-352SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-352SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-352SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-352SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-352SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-353SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-353SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-353SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-353SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68180-353SertralineSertralineLupin Pharmaceuticals, Inc.ANDACurrent
68645-589SertralineSertralineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-589SertralineSertralineLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-7329SertralineSertralinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7329SertralineSertralinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7329SertralineSertralinePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0153SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0153SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0153SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0153SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0153SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0153SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0153SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0153SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0201SertralineSertralineREMEDYREPACK INC.ANDACurrent
70518-0201SertralineSertralineREMEDYREPACK INC.ANDACurrent