ANDA 202651

HIKMA FARMACEUTICA

FDA Drug Application

Application #202651

Documents

• Review: 2013-02-26

Application Sponsors

ANDA 202651

HIKMA FARMACEUTICA

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	5MG/ML	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
002	INJECTABLE; INJECTION	50MG/10ML	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE
003	INJECTABLE; INJECTION	125MG/25ML	0	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2012-08-09

Submissions Property Types

ORIG

1

Null

42

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202651
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"50MG\/10ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DILTIAZEM HYDROCHLORIDE","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"125MG\/25ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/202651Orig1s000Approv.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-08-09
        )

)