ANDA 076604

ACTAVIS LABS FL INC

FDA Drug Application

Application #076604

Application Sponsors

ANDA 076604

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

7.5MG;200MG

0

HYDROCODONE BITARTRATE AND IBUPROFEN

HYDROCODONE BITARTRATE; IBUPROFEN

FDA Submissions

	ORIG	1	AP	2003-12-31
LABELING; Labeling	SUPPL	4	AP	2007-08-22
LABELING; Labeling	SUPPL	15	AP	2010-07-31
LABELING; Labeling	SUPPL	18	AP	2017-03-22	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-03-22	STANDARD
REMS; REMS	SUPPL	20	AP	2018-09-18
LABELING; Labeling	SUPPL	21	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-08-23	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	24	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	25	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	7
SUPPL	24	Null	7
SUPPL	25	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76604
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"7.5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND IBUPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"7.5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)