ANDA 090622

ETHYPHARM

FDA Drug Application

Application #090622

Documents

• Other: 2015-07-02

Application Sponsors

ANDA 090622

ETHYPHARM

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

	ORIG	1	AP	2010-09-24
LABELING; Labeling	SUPPL	5	AP	2013-02-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-02-04	STANDARD
REMS; REMS	SUPPL	7	AP	2013-09-04
REMS; REMS	SUPPL	12	AP	2015-02-12
LABELING; Labeling	SUPPL	13	AP	2015-02-04	STANDARD
REMS; REMS	SUPPL	17	AP	2016-07-07
LABELING; Labeling	SUPPL	18	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	19	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	21	AP	2017-05-23
LABELING; Labeling	SUPPL	25	AP	2018-02-01	STANDARD
REMS; REMS	SUPPL	26	AP	2018-10-31
LABELING; Labeling	SUPPL	30	AP	2019-10-09	STANDARD
LABELING; Labeling	SUPPL	32	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	33	AP	2022-06-16	STANDARD
LABELING; Labeling	SUPPL	34	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	35	AP	2022-05-03
LABELING; Labeling	SUPPL	36	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	37	AP	2022-12-16

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	21	Null	7
SUPPL	25	Null	15
SUPPL	26	Null	15
SUPPL	30	Null	7
SUPPL	32	Null	15
SUPPL	33	Null	7
SUPPL	34	Null	7
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	37	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ETHYPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90622
            [companyName] => ETHYPHARM
            [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":"BUPRENORPHINE HYDROCHLORIDE","submission":"BUPRENORPHINE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUPRENORPHINE HYDROCHLORIDE","submission":"BUPRENORPHINE HYDROCHLORIDE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)