ANDA 207849

CEROVENE INC

FDA Drug Application

Application #207849

Application Sponsors

ANDA 207849

CEROVENE INC

Marketing Status

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

Application Products

001	TABLET;ORAL	2.5MG	0	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE
002	TABLET;ORAL	5MG	0	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE
003	TABLET;ORAL	10MG	0	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-01

STANDARD

Submissions Property Types

ORIG

1

Null

29

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CEROVENE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207849
            [companyName] => CEROVENE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)