ANDA 077224

ZYDUS PHARMS USA

FDA Drug Application

Application #077224

Application Sponsors

ANDA 077224

ZYDUS PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

200MG

0

RIBAVIRIN

RIBAVIRIN

FDA Submissions

	ORIG	1	AP	2005-10-28
LABELING; Labeling	SUPPL	2	AP	2006-11-20
LABELING; Labeling	SUPPL	4	AP	2007-01-03
LABELING; Labeling	SUPPL	5	AP	2007-02-27
LABELING; Labeling	SUPPL	6	AP	2008-02-14
LABELING; Labeling	SUPPL	7	AP	2008-04-11
LABELING; Labeling	SUPPL	9	AP	2011-03-18
REMS; REMS	SUPPL	10	AP	2011-03-18
REMS; REMS	SUPPL	11	AP	2011-10-06
LABELING; Labeling	SUPPL	13	AP	2015-03-02	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-03-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-01-11	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-04-13	STANDARD
LABELING; Labeling	SUPPL	21	AP	2021-04-13	STANDARD
LABELING; Labeling	SUPPL	22	AP	2021-04-13	STANDARD

Submissions Property Types

SUPPL	11	Null	15
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	19	Null	15
SUPPL	21	Null	15
SUPPL	22	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77224
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIBAVIRIN","submission":"RIBAVIRIN","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)