ANDA 208938

ZYDUS PHARMS

FDA Drug Application

Application #208938

Application Sponsors

ANDA 208938

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

4MG

0

CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208938
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYPROHEPTADINE HYDROCHLORIDE","activeIngredients":"CYPROHEPTADINE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-19
        )

)