ANDA 078898

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078898

Application Sponsors

ANDA 078898

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 4MG BASE	0	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE
002	TABLET;ORAL	EQ 8MG BASE	0	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE
003	TABLET;ORAL	EQ 12MG BASE	0	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE

FDA Submissions

	ORIG	1	AP	2011-02-17
LABELING; Labeling	SUPPL	2	AP	2015-11-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-11-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-04-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-12-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-10-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	9	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78898
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GALANTAMINE HYDROBROMIDE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GALANTAMINE HYDROBROMIDE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GALANTAMINE HYDROBROMIDE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 12MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GALANTAMINE HYDROBROMIDE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GALANTAMINE HYDROBROMIDE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GALANTAMINE HYDROBROMIDE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 12MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)