ANDA 071935

AMNEAL PHARMS NY

FDA Drug Application

Application #071935

Application Sponsors

ANDA 071935

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1987-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-02-17
LABELING; Labeling	SUPPL	3	AP	1988-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-06-30
LABELING; Labeling	SUPPL	7	AP	1992-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-01-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-04-12
LABELING; Labeling	SUPPL	14	AP	1999-08-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-09-25
LABELING; Labeling	SUPPL	22	AP	2006-07-03
LABELING; Labeling	SUPPL	23	AP	2006-08-07
LABELING; Labeling	SUPPL	27	AP	2007-12-26
LABELING; Labeling	SUPPL	31	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	33	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	34	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	31	Null	15
SUPPL	33	Null	15
SUPPL	34	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71935
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)