ANDA 202978

DR REDDYS LABS LTD

FDA Drug Application

Application #202978

Documents

• Letter: 2013-01-23
• Label: 2014-01-14

Application Sponsors

ANDA 202978

DR REDDYS LABS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	30MG	0	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE
002	TABLET, ORALLY DISINTEGRATING;ORAL	30MG	0	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2013-01-18

Submissions Property Types

ORIG

1

Null

15

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202978
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/18\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202978Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/18\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202978Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202978s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2013-01-18
        )

)