ANDA 211586

AMNEAL PHARMS LLC

FDA Drug Application

Application #211586

Documents

• Letter: 2020-05-19

Application Sponsors

ANDA 211586

AMNEAL PHARMS LLC

Marketing Status

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

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	5MCG/HR	0	BUPRENORPHINE	BUPRENORPHINE
002	FILM, EXTENDED RELEASE;TRANSDERMAL	7.5MCG/HR	0	BUPRENORPHINE	BUPRENORPHINE
003	FILM, EXTENDED RELEASE;TRANSDERMAL	10MCG/HR	0	BUPRENORPHINE	BUPRENORPHINE
004	FILM, EXTENDED RELEASE;TRANSDERMAL	15MCG/HR	0	BUPRENORPHINE	BUPRENORPHINE
005	FILM, EXTENDED RELEASE;TRANSDERMAL	20MCG/HR	0	BUPRENORPHINE	BUPRENORPHINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-04-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-02-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211586
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"7.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"10MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"15MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"20MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211586Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-14
        )

)