ANDA 077971

IMPAX LABS

FDA Drug Application

Application #077971

Application Sponsors

ANDA 077971

IMPAX LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	10MG	0	BACLOFEN	BACLOFEN
002	TABLET;ORAL	20MG	0	BACLOFEN	BACLOFEN
003	TABLET;ORAL	5MG	0	BACLOFEN	BACLOFEN

FDA Submissions

	ORIG	1	AP	2007-10-26
LABELING; Labeling	SUPPL	3	AP	2022-04-19	STANDARD

Submissions Property Types

SUPPL

3

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77971
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BACLOFEN","submission":"BACLOFEN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BACLOFEN","submission":"BACLOFEN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)