ANDA 040251

MIKART

FDA Drug Application

Application #040251

Documents

• Review: 2003-07-30
• Letter: 1999-09-27
• Label: 2004-06-28

Application Sponsors

ANDA 040251

MIKART

Marketing Status

• Prescription: 001

Application Products

001

ELIXIR;ORAL

2MG/5ML

0

TRIHEXYPHENIDYL HYDROCHLORIDE

TRIHEXYPHENIDYL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1999-09-27
LABELING; Labeling	SUPPL	5	AP	2013-05-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	15

TE Codes

001

Prescription

AA

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40251
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIHEXYPHENIDYL HYDROCHLORIDE","activeIngredients":"TRIHEXYPHENIDYL HYDROCHLORIDE","strength":"2MG\/5ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/27\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/99\\\/40251_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRIHEXYPHENIDYL HYDROCHLORIDE","submission":"TRIHEXYPHENIDYL HYDROCHLORIDE","actionType":"2MG\/5ML","submissionClassification":"ELIXIR;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1999-09-27
        )

)