ANDA 078630

HIKMA FARMACEUTICA

FDA Drug Application

Application #078630

Documents

• Other Important Information from FDA: 2011-02-17

Application Sponsors

ANDA 078630

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

TERBUTALINE SULFATE

TERBUTALINE SULFATE

FDA Submissions

	ORIG	1	AP	2009-05-20
LABELING; Labeling	SUPPL	6	AP	2011-04-08

Submissions Property Types

SUPPL

6

Null

7

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78630
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERBUTALINE SULFATE","activeIngredients":"TERBUTALINE SULFATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TERBUTALINE SULFATE","submission":"TERBUTALINE SULFATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)