ANDA 091630

NATCO PHARMA LTD

FDA Drug Application

Application #091630

Application Sponsors

ANDA 091630

NATCO PHARMA LTD

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

2010-11-17

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

NATCO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91630
            [companyName] => NATCO PHARMA LTD
            [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] => 
            [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] => 1969-12-31
        )

)