ANDA 076309

DR REDDYS LABS INC

FDA Drug Application

Application #076309

Documents

• Other Important Information from FDA: 2007-05-09

Application Sponsors

ANDA 076309

DR REDDYS LABS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	50MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE
003	TABLET;ORAL	150MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE
004	TABLET;ORAL	200MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE
005	TABLET;ORAL	250MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2003-09-16
LABELING; Labeling	SUPPL	2	AP	2005-05-17
LABELING; Labeling	SUPPL	3	AP	2006-01-31
LABELING; Labeling	SUPPL	4	AP	2014-07-18	STANDARD

Submissions Property Types

SUPPL

4

Null

7

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76309
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)