ANDA 062994

WATSON LABS INC

FDA Drug Application

Application #062994

Application Sponsors

ANDA 062994

WATSON LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL

0

AMPICILLIN SODIUM

AMPICILLIN SODIUM

FDA Submissions

	ORIG	1	AP	1988-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-12-07
LABELING; Labeling	SUPPL	4	AP	1994-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1991-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-01-27
LABELING; Labeling	SUPPL	11	AP	1996-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-07-30
LABELING; Labeling	SUPPL	15	AP	1997-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-12-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62994
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)