ANDA 206119

PAR PHARM INC

FDA Drug Application

Application #206119

Documents

• Letter: 2022-08-04

Application Sponsors

ANDA 206119

PAR PHARM INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	15MG	0	TOLVAPTAN	TOLVAPTAN
002	TABLET;ORAL	30MG	0	TOLVAPTAN	TOLVAPTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206119
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLVAPTAN","activeIngredients":"TOLVAPTAN","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOLVAPTAN","activeIngredients":"TOLVAPTAN","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-15
        )

)