ANDA 077454

ANI PHARMS INC

FDA Drug Application

Application #077454

Application Sponsors

ANDA 077454

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

5MG;200MG

0

HYDROCODONE BITARTRATE AND IBUPROFEN

HYDROCODONE BITARTRATE; IBUPROFEN

FDA Submissions

	ORIG	1	AP	2010-06-23
LABELING; Labeling	SUPPL	2	AP	2018-09-21	STANDARD
REMS; REMS	SUPPL	3	AP	2018-09-18
LABELING; Labeling	SUPPL	4	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15

CDER Filings

ANI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77454
            [companyName] => ANI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND IBUPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)