ANDA 074978

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #074978

Documents

• Letter: 2014-11-13
• Review: 1998-03-25
• Label: 2014-12-19

Application Sponsors

ANDA 074978

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

100MG/5ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1998-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-11-19
LABELING; Labeling	SUPPL	3	AP	1999-11-19
LABELING; Labeling	SUPPL	4	AP	2000-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-10-25
LABELING; Labeling	SUPPL	10	AP	2003-10-29
LABELING; Labeling	SUPPL	28	AP	2008-07-31
LABELING; Labeling	SUPPL	30	AP	2010-06-03
LABELING; Labeling	SUPPL	44	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	48	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	49	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	44	Null	7
SUPPL	48	Null	15
SUPPL	49	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74978
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/25\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/074978Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"100MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-03-25
        )

)