ANDA 215939

ANNORA PHARMA

FDA Drug Application

Application #215939

Application Sponsors

ANDA 215939

ANNORA PHARMA

Marketing Status

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

Application Products

001	TABLET;ORAL	150MG	0	OXCARBAZEPINE	OXCARBAZEPINE
002	TABLET;ORAL	300MG	0	OXCARBAZEPINE	OXCARBAZEPINE
003	TABLET;ORAL	600MG	0	OXCARBAZEPINE	OXCARBAZEPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215939
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-11
        )

)