ANDA 202946

SPECGX LLC

FDA Drug Application

Application #202946

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 202946

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	7.5MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	10MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	15MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	20MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	30MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE
007	TABLET, EXTENDED RELEASE;ORAL	40MG	0	OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-06-27
REMS; REMS	SUPPL	2	AP	2015-06-26
REMS; REMS	SUPPL	3	AP	2016-04-20
LABELING; Labeling	SUPPL	4	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	5	AP	2016-09-30
LABELING; Labeling	SUPPL	6	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	7	AP	2017-05-26
REMS; REMS	SUPPL	8	AP	2018-09-18
LABELING; Labeling	SUPPL	9	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202946
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYMORPHONE HYDROCHLORIDE","activeIngredients":"OXYMORPHONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/20\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-8","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2017","submission":"SUPPL-7","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2016","submission":"SUPPL-3","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-2","supplementCategories":"REMS-Proposal","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2014","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-11
        )

)