ANDA 076642

AMNEAL PHARMS NY

FDA Drug Application

Application #076642

Documents

• Letter: 2007-10-22
• Letter: 2007-10-22
• Letter: 2007-10-22
• Letter: 2007-10-22
• Review: 2011-01-07

Application Sponsors

ANDA 076642

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	7.5MG;200MG	0	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN
002	TABLET;ORAL	5MG;200MG	0	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN
003	TABLET;ORAL	2.5MG;200MG	0	REPREXAIN	HYDROCODONE BITARTRATE; IBUPROFEN
004	TABLET;ORAL	10MG;200MG	0	REPREXAIN	HYDROCODONE BITARTRATE; IBUPROFEN

FDA Submissions

	ORIG	1	AP	2004-03-18
LABELING; Labeling	SUPPL	2	AP	2004-06-16
S; Supplement	SUPPL	3	AP	2004-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2007-10-19
LABELING; Labeling	SUPPL	6	AP	2007-10-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2007-10-19
LABELING; Labeling	SUPPL	8	AP	2007-10-19
LABELING; Labeling	SUPPL	9	AP	2007-01-03
LABELING; Labeling	SUPPL	10	AP	2007-01-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2008-03-20
LABELING; Labeling	SUPPL	20	AP	2018-08-15	STANDARD
LABELING; Labeling	SUPPL	22	AP	2018-08-15	STANDARD
LABELING; Labeling	SUPPL	23	AP	2018-08-15	STANDARD
LABELING; Labeling	SUPPL	24	AP	2018-09-21	STANDARD
REMS; REMS	SUPPL	25	AP	2018-09-18
LABELING; Labeling	SUPPL	27	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	28	AP	2019-10-10	STANDARD
LABELING; Labeling	SUPPL	30	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	32	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	20	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	7
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	27	Null	15
SUPPL	28	Null	15
SUPPL	30	Null	15
SUPPL	32	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
004	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76642
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"7.5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"HYDROCODONE BITARTRATE AND IBUPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"REPREXAIN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"2.5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"REPREXAIN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"10MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","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"},{"actionDate":"HYDROCODONE BITARTRATE AND IBUPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"REPREXAIN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"2.5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"REPREXAIN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"10MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)