ANDA 207338

ACTAVIS LABS FL INC

FDA Drug Application

Application #207338

Documents

• Letter: 2017-12-18

Application Sponsors

ANDA 207338

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	TABLET;SUBLINGUAL	EQ 0.1MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
002	TABLET;SUBLINGUAL	EQ 0.2MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
003	TABLET;SUBLINGUAL	EQ 0.3MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
004	TABLET;SUBLINGUAL	EQ 0.4MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
005	TABLET;SUBLINGUAL	EQ 0.6MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE
006	TABLET;SUBLINGUAL	EQ 0.8MG BASE	0	FENTANYL CITRATE	FENTANYL CITRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-17	STANDARD
REMS; REMS	SUPPL	2	AP	2021-12-03
REMS; REMS	SUPPL	3	AP	2022-08-17
REMS; REMS	SUPPL	4	AP	2022-12-08

Submissions Property Types

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

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207338
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.1MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.2MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.3MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.4MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.6MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.8MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207338Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/03\/2021","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/23\/2020","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-12-03
        )

)