ANDA 078432

AMNEAL PHARMS NY

FDA Drug Application

Application #078432

Documents

• Other Important Information from FDA: 2007-05-08

Application Sponsors

ANDA 078432

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 250MG BASE	0	NAPROXEN SODIUM	NAPROXEN SODIUM
002	TABLET;ORAL	EQ 500MG BASE	0	NAPROXEN SODIUM	NAPROXEN SODIUM

FDA Submissions

	ORIG	1	AP	2007-04-25
LABELING; Labeling	SUPPL	3	AP	2015-05-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-12-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-12-03	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-12-03	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	9	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78432
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)