ANDA 202321

SPECGX LLC

FDA Drug Application

Application #202321

Application Sponsors

ANDA 202321

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2013-04-25
LABELING; Labeling	SUPPL	2	AP	2021-02-04	STANDARD
REMS; REMS	SUPPL	3	AP	2018-09-18
LABELING; Labeling	SUPPL	6	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	6	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202321
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/25\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-3","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)