ANDA 078484

IMPAX LABS

FDA Drug Application

Application #078484

Application Sponsors

ANDA 078484

IMPAX LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	EQ 8MG BASE	0	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	EQ 16MG BASE	0	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	EQ 24MG BASE	0	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE

FDA Submissions

	ORIG	1	AP	2009-05-27
LABELING; Labeling	SUPPL	8	AP	2019-12-06	STANDARD

Submissions Property Types

SUPPL

8

Null

7

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78484
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GALANTAMINE HYDROBROMIDE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 8MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GALANTAMINE HYDROBROMIDE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 16MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GALANTAMINE HYDROBROMIDE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 24MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GALANTAMINE HYDROBROMIDE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 8MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GALANTAMINE HYDROBROMIDE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 16MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GALANTAMINE HYDROBROMIDE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 24MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)