ANDA 077094

ZYDUS PHARMS USA

FDA Drug Application

Application #077094

Documents

• Letter: 2005-10-20

Application Sponsors

ANDA 077094

ZYDUS PHARMS USA

Marketing Status

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

Application Products

001	TABLET;ORAL	200MG	0	RIBAVIRIN	RIBAVIRIN
002	TABLET;ORAL	400MG	0	RIBAVIRIN	RIBAVIRIN
003	TABLET;ORAL	600MG	0	RIBAVIRIN	RIBAVIRIN
004	TABLET;ORAL	500MG	0	RIBAVIRIN	RIBAVIRIN

FDA Submissions

	ORIG	1	AP	2005-12-05
LABELING; Labeling	SUPPL	2	AP	2007-03-16
LABELING; Labeling	SUPPL	5	AP	2007-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2008-03-20
LABELING; Labeling	SUPPL	7	AP	2014-09-11
LABELING; Labeling	SUPPL	11	AP	2008-04-18
LABELING; Labeling	SUPPL	12	AP	2008-01-04
LABELING; Labeling	SUPPL	14	AP	2008-05-14
LABELING; Labeling	SUPPL	15	AP	2008-07-23
LABELING; Labeling	SUPPL	17	AP	2010-09-16
REMS; REMS	SUPPL	18	AP	2011-03-10
REMS; REMS	SUPPL	19	AP	2011-11-10
LABELING; Labeling	SUPPL	20	AP	2015-05-04
LABELING; Labeling	SUPPL	21	AP	2015-05-04	STANDARD
LABELING; Labeling	SUPPL	23	AP	2015-09-25	STANDARD

Submissions Property Types

ORIG	1	Null	36
SUPPL	6	Null	0
SUPPL	7	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	7
SUPPL	21	Null	7
SUPPL	23	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77094
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIBAVIRIN","submission":"RIBAVIRIN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RIBAVIRIN","submission":"RIBAVIRIN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RIBAVIRIN","submission":"RIBAVIRIN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RIBAVIRIN","submission":"RIBAVIRIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)