ANDA 076264

SPECGX LLC

FDA Drug Application

Application #076264

Documents

• Letter: 2003-04-11
• Review: 2007-05-09

Application Sponsors

ANDA 076264

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	25MG	0	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE
002	TABLET;ORAL	50MG	0	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE
003	TABLET;ORAL	100MG	0	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2002-03-22

TE Codes

002

Prescription

AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76264
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALTREXONE HYDROCHLORIDE","activeIngredients":"NALTREXONE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NALTREXONE HYDROCHLORIDE","activeIngredients":"NALTREXONE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"NALTREXONE HYDROCHLORIDE","activeIngredients":"NALTREXONE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NALTREXONE HYDROCHLORIDE","submission":"NALTREXONE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NALTREXONE HYDROCHLORIDE","submission":"NALTREXONE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NALTREXONE HYDROCHLORIDE","submission":"NALTREXONE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)