ANDA 203018

SCIEGEN PHARMS INC

FDA Drug Application

Application #203018

Application Sponsors

ANDA 203018

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	25MG	0	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	50MG	0	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-07-23
LABELING; Labeling	SUPPL	7	AP	2020-08-20	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203018
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/23\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-20
        )

)