ANDA 207466

SCIEGEN PHARMS INC

FDA Drug Application

Application #207466

Application Sponsors

ANDA 207466

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	800MG	0	METAXALONE	METAXALONE
002	TABLET;ORAL	400MG	0	METAXALONE	METAXALONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-09-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207466
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METAXALONE","activeIngredients":"METAXALONE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METAXALONE","activeIngredients":"METAXALONE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/27\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-27
        )

)