FDA.report

Application 019839

Type
NDA
Sponsor
PFIZER

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLOFTSERTRALINE HYDROCHLORIDETABLET;ORALEQ 50MG BASEYesNo
002ZOLOFTSERTRALINE HYDROCHLORIDETABLET;ORALEQ 100MG BASEYesYes
003ZOLOFTSERTRALINE HYDROCHLORIDETABLET;ORALEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004ZOLOFTSERTRALINE HYDROCHLORIDETABLET;ORALEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005ZOLOFTSERTRALINE HYDROCHLORIDETABLET;ORALEQ 25MG BASEYesNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4900Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4910Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4960Zoloftsertraline hydrochlorideRoerigNDACurrent
43063-411SERTRALINE HYDROCHLORIDEsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-411SERTRALINE HYDROCHLORIDEsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
53808-0582SERTRALINE HYDROCHLORIDEsertraline hydrochlorideState of Florida DOH Central PharmacyNDACurrent
55154-0527SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCardinal HealthNDACurrent
55154-0532SERTRALINE HYDROCHLORIDEsertraline hydrochlorideCardinal HealthNDACurrent
55289-381SERTRALINE HYDROCHLORIDEsertraline hydrochloridePD-Rx Pharmaceuticals, InNDA AUTHORIZED Current
55289-381SERTRALINE HYDROCHLORIDEsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-409Zoloftsertraline hydrochloridePD-Rx Pharmaceuticals, InNDACurrent
55289-409Zoloftsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-409Zoloftsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-409Zoloftsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-409Zoloftsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-409Zoloftsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-409Zoloftsertraline hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
59762-4900SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4900SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4910SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4960SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5160SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5160SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5160SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5160SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5160SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6347SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6347SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6347SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6347SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6347SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6443SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6443SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6443SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6443SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6443SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
63629-6755SERTRALINE HYDROCHLORIDEsertraline hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6755SERTRALINE HYDROCHLORIDEsertraline hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
67046-665SERTRALINE HYDROCHLORIDEsertraline hydrochlorideContract Pharmacy Services-PANDACurrent
67544-080ZoloftSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-298ZoloftSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCNDACurrent
70518-1913Zoloftsertraline hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1913Zoloftsertraline hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1913Zoloftsertraline hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1913Zoloftsertraline hydrochlorideREMEDYREPACK INC.NDACurrent
71610-433SERTRALINE HYDROCHLORIDEsertraline hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
75921-490SERTRALINE HYDROCHLORIDEsertraline hydrochlorideLife Line Home Care ServicesNDACurrent

Documents

DocumentSubmission typeDate
75230SUPPL 2023-08-22
75206SUPPL 2023-08-22
75205SUPPL 2023-08-22
73310SUPPL2023-01-30
73309SUPPL2023-01-30
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68705SUPPL2021-09-21
68704SUPPL2021-09-21
68673SUPPL2021-09-21
50721SUPPL2017-12-18
50720SUPPL2017-12-18
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50662SUPPL2017-12-12
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46549SUPPL2016-12-27
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11763SUPPL2014-09-19
19287SUPPL2014-09-16
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