ANDA 075604

ACTAVIS LABS FL INC

FDA Drug Application

Application #075604

Documents

• Letter: 2003-04-10

Application Sponsors

ANDA 075604

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	10MEQ	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	20MEQ	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE

FDA Submissions

	ORIG	1	AP	2002-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-24
LABELING; Labeling	SUPPL	15	AP	2008-11-24

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

TE Codes

001	Prescription	AB1
002	Prescription	AB1

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75604
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"10MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"20MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)