ANDA 074517

YAOPHARMA CO LTD

FDA Drug Application

Application #074517

Documents

• Letter: 1998-09-30
• Label: 2004-06-04
• Review: 2003-08-01

Application Sponsors

ANDA 074517

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 4MG BASE	0	GUANABENZ ACETATE	GUANABENZ ACETATE
002	TABLET;ORAL	EQ 8MG BASE	0	GUANABENZ ACETATE	GUANABENZ ACETATE

FDA Submissions

ORIG

1

AP

1998-09-30

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74517
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUANABENZ ACETATE","activeIngredients":"GUANABENZ ACETATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GUANABENZ ACETATE","activeIngredients":"GUANABENZ ACETATE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/30\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/74517_Guanabenz%20Acetate_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GUANABENZ ACETATE","submission":"GUANABENZ ACETATE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GUANABENZ ACETATE","submission":"GUANABENZ ACETATE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-09-30
        )

)