ANDA 076855

SPECGX LLC

FDA Drug Application

Application #076855

Application Sponsors

ANDA 076855

SPECGX LLC

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2004-12-23
LABELING; Labeling	SUPPL	4	AP	2006-11-09
LABELING; Labeling	SUPPL	5	AP	2008-02-06
LABELING; Labeling	SUPPL	12	AP	2020-03-09	STANDARD
REMS; REMS	SUPPL	13	AP	2018-09-18
LABELING; Labeling	SUPPL	14	AP	2020-03-09	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-03-09	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	17	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76855
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)