ANDA 203646

SCIEGEN PHARMS INC

FDA Drug Application

Application #203646

Application Sponsors

ANDA 203646

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-09-09
LABELING; Labeling	SUPPL	6	AP	2017-12-27	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-12-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-12-27	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-12-27	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-08-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-08-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-08-29	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203646
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/29\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/29\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/29\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/27\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/27\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/27\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/27\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-29
        )

)