ANDA 078957

HETERO LABS LTD III

FDA Drug Application

Application #078957

Documents

• Letter: 2008-03-04
• Letter: 2008-12-31

Application Sponsors

ANDA 078957

HETERO LABS LTD III

Marketing Status

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

Application Products

001	CAPSULE;ORAL	15MG	0	STAVUDINE	STAVUDINE
002	CAPSULE;ORAL	20MG	0	STAVUDINE	STAVUDINE
003	CAPSULE;ORAL	30MG	0	STAVUDINE	STAVUDINE
004	CAPSULE;ORAL	40MG	0	STAVUDINE	STAVUDINE

FDA Submissions

	ORIG	1	AP	2008-12-29
LABELING; Labeling	SUPPL	2	AP	2009-09-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2015-06-24	UNKNOWN

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	5	Null	15

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78957
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"STAVUDINE","activeIngredients":"STAVUDINE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STAVUDINE","activeIngredients":"STAVUDINE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STAVUDINE","activeIngredients":"STAVUDINE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STAVUDINE","activeIngredients":"STAVUDINE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STAVUDINE","submission":"STAVUDINE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STAVUDINE","submission":"STAVUDINE","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STAVUDINE","submission":"STAVUDINE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STAVUDINE","submission":"STAVUDINE","actionType":"40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)