ANDA 077311

NESHER PHARMS

FDA Drug Application

Application #077311

Documents

• Other Important Information from FDA: 2005-11-21

Application Sponsors

ANDA 077311

NESHER PHARMS

Marketing Status

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

Application Products

001	TABLET;ORAL	2MG	0	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE
002	TABLET;ORAL	4MG	0	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE
003	TABLET;ORAL	8MG	0	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2005-11-09

Submissions Property Types

ORIG

1

Null

0

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77311
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)