WATSON LABS INC FDA Approval ANDA 062991

ANDA 062991

WATSON LABS INC

FDA Drug Application

Application #062991

Application Sponsors

ANDA 062991WATSON LABS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001INJECTABLE;INJECTION1,000,000 UNITS/VIAL0PENICILLIN G POTASSIUMPENICILLIN G POTASSIUM
002INJECTABLE;INJECTION5,000,000 UNITS/VIAL0PENICILLIN G POTASSIUMPENICILLIN G POTASSIUM
003INJECTABLE;INJECTION10,000,000 UNITS/VIAL0PENICILLIN G POTASSIUMPENICILLIN G POTASSIUM
004INJECTABLE;INJECTION20,000,000 UNITS/VIAL0PENICILLIN G POTASSIUMPENICILLIN G POTASSIUM

FDA Submissions

ORIG1AP1988-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1988-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1989-02-03
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1989-02-03
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1991-01-23
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1989-07-18
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1993-11-17
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1993-11-17
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1994-01-13
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1995-01-27
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1995-01-27
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1995-06-28
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1998-01-28
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1999-05-07
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2000-12-08

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0

CDER Filings

WATSON LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62991
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"1,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"5,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"10,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"20,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PENICILLIN G POTASSIUM","submission":"PENICILLIN G POTASSIUM","actionType":"1,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PENICILLIN G POTASSIUM","submission":"PENICILLIN G POTASSIUM","actionType":"5,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PENICILLIN G POTASSIUM","submission":"PENICILLIN G POTASSIUM","actionType":"10,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PENICILLIN G POTASSIUM","submission":"PENICILLIN G POTASSIUM","actionType":"20,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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