ANDA 204431

ETHYPHARM USA CORP

FDA Drug Application

Application #204431

Documents

• Label: 2015-11-25
• Letter: 2015-10-21
• Other: 2016-02-03

Application Sponsors

ANDA 204431

ETHYPHARM USA CORP

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	2015-10-16	STANDARD
REMS; REMS	SUPPL	5	AP	2016-07-07
LABELING; Labeling	SUPPL	6	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2016-10-31	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2018-01-31	STANDARD
REMS; REMS	SUPPL	12	AP	2017-05-23
LABELING; Labeling	SUPPL	13	AP	2018-02-01	STANDARD
REMS; REMS	SUPPL	14	AP	2018-10-31
LABELING; Labeling	SUPPL	17	AP	2019-10-09	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-03-15	STANDARD
LABELING; Labeling	SUPPL	22	AP	2022-06-16	STANDARD
LABELING; Labeling	SUPPL	24	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	25	AP	2022-05-03
LABELING; Labeling	SUPPL	26	AP	2022-06-17	STANDARD
REMS; REMS	SUPPL	27	AP	2022-12-16

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	15
SUPPL	17	Null	7
SUPPL	19	Null	7
SUPPL	22	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	Null	15
SUPPL	27	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ETHYPHARM USA CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204431
            [companyName] => ETHYPHARM USA CORP
            [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] => [{"actionDate":"10\/16\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204431Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204431Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204431Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/09\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2018","submission":"SUPPL-14","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/23\/2017","submission":"SUPPL-12","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/31\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/07\/2016","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-09
        )

)