ANDA 207276

RHODES PHARMS

FDA Drug Application

Application #207276

Documents

• REMS: 2017-10-12

Application Sponsors

ANDA 207276

RHODES PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-27	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-02-01	STANDARD
REMS; REMS	SUPPL	4	AP	2018-10-31
LABELING; Labeling	SUPPL	8	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-06-13	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	12	AP	2022-05-03
LABELING; Labeling	SUPPL	13	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	14	AP	2022-12-16

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207276
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/31\/2018","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/23\/2017","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-10-31
        )

)