Trihexyphenidyl Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmaceutical Associates, Inc. (2011-02-23)
Oldest Current Product
1997-05-15
License(s)
ANDA
RxNORM
ORAL SOLUTION\TRIHEXYPHENIDYL
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\TRIHEXYPHENIDYL HYDROCHLORIDE
ORAL\ELIXIR\TRIHEXYPHENIDYL HYDROCHLORIDE
ORAL\TABLET\TRIHEXYPHENIDYL HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\TRIHEXYPHENIDYL HYDROCHLORIDE
ORAL\SYRUP\TRIHEXYPHENIDYL HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\TRIHEXYPHENIDYL
ORAL\SYRUP\TRIHEXYPHENIDYL

product(s) by strength(s)

trihexyphenidyl hydrochloride 0.4 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001210658ANDAPharmaceutical Associates, Inc.1997-05-15TRIHEXYPHENIDYL HYDROCHLORIDEORALSOLUTIONANDA0401779036c9f0-6d2d-4d0f-a20e-e36f9be228f7
2466720635ANDAMikart, Inc.1999-10-04TRIHEXYPHENIDYL HYDROCHLORIDEORALSOLUTIONANDA040251d6f08000-e973-4bab-810c-b69f6c8ee4f3
3617480054ANDAVersapharm Incorporated2001-03-01TRIHEXYPHENIDYL HYDROCHLORIDEORALSYRUPANDA040251294cd88d-d9e8-4938-b4be-c3adc4a35de0

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040177TRIHEXYPHENIDYL HYDROCHLORIDEPHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS1997-04-17ANDA040177_001
2ANDA040251TRIHEXYPHENIDYL HYDROCHLORIDEMIKART INC1999-09-27ANDA040251_001
3ANDA089514TRIHEXYPHENIDYL HYDROCHLORIDETruePHARMACEUTICAL VENTURES LTD1989-04-07ANDA089514_001
4NDA006773ARTANETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID CONDA006773_003, NDA006773_005, NDA006773_009, NDA006773_010Trihexyphenidyl Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040177_001RXTRIHEXYPHENIDYL HYDROCHLORIDE (2MG/5ML)ORALELIXIRTrueAA1997-04-17TRIHEXYPHENIDYL HYDROCHLORIDE
2ANDA040251_001RXTRIHEXYPHENIDYL HYDROCHLORIDE (2MG/5ML)ORALELIXIRFalseAA1999-09-27TRIHEXYPHENIDYL HYDROCHLORIDE
3ANDA089514_001discontinuedTRIHEXYPHENIDYL HYDROCHLORIDE (2MG/5ML)ORALELIXIRFalse1989-04-07TRIHEXYPHENIDYL HYDROCHLORIDE
4NDA006773_003discontinuedTRIHEXYPHENIDYL HYDROCHLORIDE (5MG)ORALTABLETFalseARTANE
5NDA006773_005discontinuedTRIHEXYPHENIDYL HYDROCHLORIDE (2MG)ORALTABLETFalseARTANE
6NDA006773_009discontinuedTRIHEXYPHENIDYL HYDROCHLORIDE (2MG/5ML)ORALELIXIRFalseARTANE
7NDA006773_010discontinuedTRIHEXYPHENIDYL HYDROCHLORIDE (5MG)ORALCAPSULE, EXTENDED RELEASEFalseARTANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1294cd88d-d9e8-4938-b4be-c3adc4a35de0 (view SPL)Trihexyphenidyl Hydrochloride Oral Solution, USP 2 mg per 5 mLprescriptionHuman PrescriptionVersapharm IncorporatedANALYSIS, MANUFACTURE, PACK2013-05-225617480054
29036c9f0-6d2d-4d0f-a20e-e36f9be228f7 (view SPL)Trihexyphenidyl Hydrochloride Oral Solution USP2 mg per 5 mLprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2011-02-232001210658
3d6f08000-e973-4bab-810c-b69f6c8ee4f3 (view SPL)prescriptionHuman PrescriptionMikart, Inc.2013-04-121466720635

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII