ANDA 212925

ACIC PHARMS

FDA Drug Application

Application #212925

Application Sponsors

ANDA 212925

ACIC PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	200MG	0	CELECOXIB	CELECOXIB
002	CAPSULE;ORAL	400MG	0	CELECOXIB	CELECOXIB

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACIC PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212925
            [companyName] => ACIC PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-09
        )

)