ANDA 063014

WATSON LABS INC

FDA Drug Application

Application #063014

Documents

• Review: 2016-07-28

Application Sponsors

ANDA 063014

WATSON LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

5,000,000 UNITS/VIAL

0

PENICILLIN G SODIUM

PENICILLIN G SODIUM

FDA Submissions

	ORIG	1	AP	1988-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-11-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-12-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 63014
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLIN G SODIUM","activeIngredients":"PENICILLIN G SODIUM","strength":"5,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PENICILLIN G SODIUM","submission":"PENICILLIN G SODIUM","actionType":"5,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)