ANDA 040254

NOVITIUM PHARMA

FDA Drug Application

Application #040254

Documents

• Label: 2004-06-28
• Letter: 1998-12-24
• Review: 2003-07-31

Application Sponsors

ANDA 040254

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	2MG	0	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE
002	TABLET;ORAL	5MG	0	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1998-12-24
LABELING; Labeling	SUPPL	2	AP	2000-09-29

Submissions Property Types

SUPPL

1

Null

0

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40254
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIHEXYPHENIDYL HYDROCHLORIDE","activeIngredients":"TRIHEXYPHENIDYL HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIHEXYPHENIDYL HYDROCHLORIDE","activeIngredients":"TRIHEXYPHENIDYL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/24\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/40254_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRIHEXYPHENIDYL HYDROCHLORIDE","submission":"TRIHEXYPHENIDYL HYDROCHLORIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TRIHEXYPHENIDYL HYDROCHLORIDE","submission":"TRIHEXYPHENIDYL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-12-24
        )

)