FDA.reportPublic FDA data

Application 040251

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEELIXIR;ORAL2MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-635trihexyphenidyl hydrochloridetrihexyphenidyl hydrochlorideMikart, Inc.ANDACurrent
46672-635trihexyphenidyl hydrochloridetrihexyphenidyl hydrochlorideMikart, LLCANDACurrent
61748-054Trihexyphenidyl HydrochlorideTrihexyphenidyl HydrochlorideAkornANDACurrent
61748-054Trihexyphenidyl HydrochlorideTrihexyphenidyl HydrochlorideVersaPharm, Inc. - An Akorn CompanyANDACurrent
61748-054Trihexyphenidyl HydrochlorideTrihexyphenidyl HydrochlorideVersapharm IncorporatedANDACurrent
70518-3288Trihexyphenidyl HydrochlorideTrihexyphenidyl HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38872ORIG2004-06-28
22105ORIG2003-07-30
29900ORIG1999-09-27