ANDA 060770

HIKMA PHARMS

FDA Drug Application

Application #060770

Application Sponsors

ANDA 060770

HIKMA PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

EQ 250MG BASE

0

OXYTETRACYCLINE HYDROCHLORIDE

OXYTETRACYCLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1967-09-29
LABELING; Labeling	SUPPL	2	AP	1990-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-06-11

Submissions Property Types

SUPPL

3

Null

0

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60770
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYTETRACYCLINE HYDROCHLORIDE","activeIngredients":"OXYTETRACYCLINE HYDROCHLORIDE","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYTETRACYCLINE HYDROCHLORIDE","submission":"OXYTETRACYCLINE HYDROCHLORIDE","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)