ANDA 204937

WATSON LABS TEVA

FDA Drug Application

Application #204937

Documents

• Letter: 2018-12-20

Application Sponsors

ANDA 204937

WATSON LABS TEVA

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-04-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2021-06-29
LABELING; Labeling	SUPPL	6	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15

TE Codes

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

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204937
            [companyName] => WATSON LABS TEVA
            [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":"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"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"7.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204937Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/28\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/29\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2021","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/28\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-06-29
        )

)