FDA.reportPublic FDA data

Application 211642

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THIOTHIXENETHIOTHIXENECAPSULE;ORAL1MGNoNo
002THIOTHIXENETHIOTHIXENECAPSULE;ORAL2MGNoNo
003THIOTHIXENETHIOTHIXENECAPSULE;ORAL5MGNoYes
004THIOTHIXENETHIOTHIXENECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-275ThiothixeneThiothixeneGolden State Medical Supply, Inc.ANDACurrent
51407-275ThiothixeneThiothixeneGolden State Medical Supply, Inc.ANDACurrent
51407-276ThiothixeneThiothixeneGolden State Medical Supply, Inc.ANDACurrent
51407-276ThiothixeneThiothixeneGolden State Medical Supply, Inc.ANDACurrent
51407-277ThiothixeneThiothixeneGolden State Medical Supply, Inc.ANDACurrent
51407-277ThiothixeneThiothixeneGolden State Medical Supply, Inc.ANDACurrent
51407-278ThiothixeneThiothixeneGolden State Medical Supply, Inc.ANDACurrent
51407-278ThiothixeneThiothixeneGolden State Medical Supply, Inc.ANDACurrent
70518-2544ThiothixeneThiothixeneREMEDYREPACK INC.ANDACurrent
70518-2544ThiothixeneThiothixeneREMEDYREPACK INC.ANDACurrent
70518-2594ThiothixeneThiothixeneREMEDYREPACK INC.ANDACurrent
70518-2594ThiothixeneThiothixeneREMEDYREPACK INC.ANDACurrent
70518-2594ThiothixeneThiothixeneREMEDYREPACK INC.ANDACurrent
70954-014ThiothixeneThiothixeneNovitium Pharma LLCANDACurrent
70954-014ThiothixeneThiothixeneNovitium Pharma LLCANDACurrent
70954-015ThiothixeneThiothixeneNovitium Pharma LLCANDACurrent
70954-015ThiothixeneThiothixeneNovitium Pharma LLCANDACurrent
70954-016ThiothixeneThiothixeneNovitium Pharma LLCANDACurrent
70954-016ThiothixeneThiothixeneNovitium Pharma LLCANDACurrent
70954-017ThiothixeneThiothixeneNovitium Pharma LLCANDACurrent
70954-017ThiothixeneThiothixeneNovitium Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58823ORIG2019-05-22