ANDA 078030

CIPLA LTD

FDA Drug Application

Application #078030

Documents

• Letter: 2009-03-24

Application Sponsors

ANDA 078030

CIPLA LTD

Marketing Status

• Discontinued: 001

Application Products

001

FOR SOLUTION;ORAL

1MG/ML

0

STAVUDINE

STAVUDINE

FDA Submissions

	ORIG	1	AP	2009-03-20
LABELING; Labeling	SUPPL	3	AP	2011-11-08
LABELING; Labeling	SUPPL	4	AP	2016-02-16
LABELING; Labeling	SUPPL	6	AP	2020-02-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-02-10	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	8
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78030
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"STAVUDINE","activeIngredients":"STAVUDINE","strength":"1MG\/ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STAVUDINE","submission":"STAVUDINE","actionType":"1MG\/ML","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)