ANDA 212517

SCIEGEN PHARMS INC

FDA Drug Application

Application #212517

Application Sponsors

ANDA 212517

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	250MG	0	NAPROXEN	NAPROXEN
002	TABLET;ORAL	375MG	0	NAPROXEN	NAPROXEN
003	TABLET;ORAL	500MG	0	NAPROXEN	NAPROXEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-02-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212517
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-21
        )

)