ANDA 080880

IMPAX LABS

FDA Drug Application

Application #080880

Application Sponsors

ANDA 080880

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

250MG

0

CHLOROQUINE PHOSPHATE

CHLOROQUINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1974-12-11
LABELING; Labeling	SUPPL	39	AP	1988-11-22
LABELING; Labeling	SUPPL	40	AP	1988-12-15
LABELING; Labeling	SUPPL	43	AP	1996-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1997-07-18
LABELING; Labeling	SUPPL	63	AP	2020-04-30	STANDARD
LABELING; Labeling	SUPPL	65	AP	2022-03-17	STANDARD
LABELING; Labeling	SUPPL	66	AP	2022-05-03	STANDARD

Submissions Property Types

SUPPL	45	Null	0
SUPPL	63	Null	15
SUPPL	65	Null	15
SUPPL	66	Null	15

TE Codes

001

Prescription

AA

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80880
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLOROQUINE PHOSPHATE","activeIngredients":"CHLOROQUINE PHOSPHATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLOROQUINE PHOSPHATE","submission":"CHLOROQUINE PHOSPHATE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)