ANDA 074566

PLIVA

FDA Drug Application

Application #074566

Application Sponsors

ANDA 074566

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

0

CIMETIDINE

CIMETIDINE

FDA Submissions

	ORIG	1	AP	1997-02-27
LABELING; Labeling	SUPPL	7	AP	2005-03-03

Submissions Property Types

SUPPL

1

Null

0

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74566
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)