ANDA 064204

WATSON LABS INC

FDA Drug Application

Application #064204

Documents

• Review: 1998-02-16

Application Sponsors

ANDA 064204

WATSON LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

FOR SUSPENSION;ORAL

EQ 125MG BASE/5ML

0

CEFACLOR

CEFACLOR

FDA Submissions

	ORIG	1	AP	1998-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-03-05
LABELING; Labeling	SUPPL	4	AP	1999-05-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-12-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64204
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFACLOR","activeIngredients":"CEFACLOR","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFACLOR","submission":"CEFACLOR","actionType":"EQ 125MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)