ANDA 203374

SCIEGEN PHARMS INC

FDA Drug Application

Application #203374

Application Sponsors

ANDA 203374

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

350MG

0

CARISOPRODOL

CARISOPRODOL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-01-27
LABELING; Labeling	SUPPL	12	AP	2019-04-02	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	12	Null	15

TE Codes

001

Prescription

AA

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203374
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/02\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-02
        )

)