ANDA 207000

SPECGX LLC

FDA Drug Application

Application #207000

Application Sponsors

ANDA 207000

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;SUBLINGUAL	EQ 2MG BASE;EQ 0.5MG BASE	0	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
002	TABLET;SUBLINGUAL	EQ 8MG BASE;EQ 2MG BASE	0	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-13	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-09-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-10-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-02-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-06-14	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	22	AP	2022-05-03
LABELING; Labeling	SUPPL	24	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	27	AP	2022-12-16

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	16	Null	7
SUPPL	21	Null	7
SUPPL	22	Null	31
SUPPL	24	Null	7
SUPPL	27	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207000
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2MG BASE;EQ 0.5MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8MG BASE;EQ 2MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/08\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2018","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-08
        )

)