ANDA 075927

AMNEAL PHARMS NY

FDA Drug Application

Application #075927

Application Sponsors

ANDA 075927

AMNEAL PHARMS NY

Marketing Status

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

Application Products

001	TABLET;ORAL	250MG	0	NAPROXEN	NAPROXEN
002	TABLET;ORAL	375MG	0	NAPROXEN	NAPROXEN
003	TABLET;ORAL	500MG	0	NAPROXEN	NAPROXEN

FDA Submissions

	ORIG	1	AP	2001-12-18
LABELING; Labeling	SUPPL	6	AP	2006-05-19
LABELING; Labeling	SUPPL	11	AP	2007-10-16
LABELING; Labeling	SUPPL	21	AP	2014-11-02	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	27	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	31	AP	2019-11-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	21	Null	15
SUPPL	25	Null	15
SUPPL	27	Null	15
SUPPL	31	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75927
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)