ANDA 076192

CHARTWELL RX

FDA Drug Application

Application #076192

Documents

• Label: 2004-04-09
• Letter: 2004-04-07
• Exclusivity Letter: 2004-04-09

Application Sponsors

ANDA 076192

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

200MG

0

RIBAVIRIN

RIBAVIRIN

FDA Submissions

	ORIG	1	AP	2004-04-06
LABELING; Labeling	SUPPL	3	AP	2006-03-28
LABELING; Labeling	SUPPL	11	AP	2008-01-04
LABELING; Labeling	SUPPL	12	AP	2008-07-21
LABELING; Labeling	SUPPL	15	AP	2011-08-01
LABELING; Labeling	SUPPL	16	AP	2014-07-08	STANDARD
LABELING; Labeling	SUPPL	17	AP	2014-07-08	STANDARD
LABELING; Labeling	SUPPL	18	AP	2014-07-08	STANDARD
LABELING; Labeling	SUPPL	20	AP	2016-01-11	STANDARD

Submissions Property Types

SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	15
SUPPL	20	Null	7

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76192
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/06\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/76192lbl_Ribavarin_Sandoz.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RIBAVIRIN","submission":"RIBAVIRIN","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2004-04-06
        )

)