ANDA 205431

TRIS PHARMA INC

FDA Drug Application

Application #205431

Application Sponsors

ANDA 205431

TRIS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

2MG/5ML

0

CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205431
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYPROHEPTADINE HYDROCHLORIDE","activeIngredients":"CYPROHEPTADINE HYDROCHLORIDE","strength":"2MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-21
        )

)