FDA.reportPublic FDA data

Application 040254

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDETABLET;ORAL2MGNoNo
002TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-6240Trihexyphenidyl Hydrochloridetrihexyphenidyl hydrochlorideQualitest PharmaceuticalsANDACurrent
50090-5205TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEA-S Medication SolutionsANDACurrent
51407-265TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.ANDACurrent
51407-265TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.ANDACurrent
51407-265TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.ANDACurrent
51407-266TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.ANDACurrent
51407-266TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.ANDACurrent
51407-266TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.ANDACurrent
53808-0633Trihexyphenidyl Hydrochloridetrihexyphenidyl hydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0634Trihexyphenidyl Hydrochloridetrihexyphenidyl hydrochlorideState of Florida DOH Central PharmacyANDACurrent
54738-554Trihexyphenidyl Hydrochloridetrihexyphenidyl hydrochlorideRichmond Pharmaceuticals, Inc.ANDACurrent
54738-555Trihexyphenidyl Hydrochloridetrihexyphenidyl hydrochlorideRichmond Pharmaceuticals, Inc.ANDACurrent
70518-0357Trihexyphenidyl Hydrochloridetrihexyphenidyl hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2409TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2409TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2409TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2409TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2410TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2410TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2410TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70954-211TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDENovitium Pharma LLCANDACurrent
70954-212TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDENovitium Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17755ORIG2004-06-28
42601ORIG2003-07-31
29901ORIG1998-12-24