ANDA 216961

TEVA PHARMS INC

FDA Drug Application

Application #216961

Application Sponsors

ANDA 216961

TEVA PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	300MG	0	THEOPHYLLINE	THEOPHYLLINE
002	TABLET, EXTENDED RELEASE;ORAL	450MG	0	THEOPHYLLINE	THEOPHYLLINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TEVA PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216961
            [companyName] => TEVA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"450MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/12\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-12
        )

)