ANDA 075326

YAOPHARMA CO LTD

FDA Drug Application

Application #075326

Documents

• Letter: 1999-08-20
• Review: 2001-12-20
• Label: 2004-06-18

Application Sponsors

ANDA 075326

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

250MG

0

TICLOPIDINE HYDROCHLORIDE

TICLOPIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1999-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-02-10
LABELING; Labeling	SUPPL	3	AP	2000-10-04
LABELING; Labeling	SUPPL	4	AP	2002-12-19

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75326
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TICLOPIDINE HYDROCHLORIDE","activeIngredients":"TICLOPIDINE HYDROCHLORIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/20\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/99\\\/75-326_Ticlopidine%20Hydrochloride_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TICLOPIDINE HYDROCHLORIDE","submission":"TICLOPIDINE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1999-08-20
        )

)