ANDA 091534

ZYDUS PHARMS USA INC

FDA Drug Application

Application #091534

Application Sponsors

ANDA 091534

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 25MG BASE/ML

0

RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2013-02-22

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AP

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91534
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 25MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 25MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)