ANDA 077760

HIKMA FARMACEUTICA

FDA Drug Application

Application #077760

Application Sponsors

ANDA 077760

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-01-31
LABELING; Labeling	SUPPL	8	AP	2015-07-01

Submissions Property Types

SUPPL

8

Null

15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77760
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)