NDA 020551

ABBVIE

FDA Drug Application

Application #020551

Documents

• Letter: 2002-06-04
• Letter: 2010-11-30
• Letter: 2003-07-28
• Letter: 2010-06-08
• Label: 2010-11-22
• Label: 2018-07-27
• Label: 2018-10-24
• Letter: 2018-07-30
• Letter: 2018-07-30
• Letter: 2022-10-11
• Letter: 2022-10-17
• Label: 2022-10-17

Application Sponsors

NDA 020551

ABBVIE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	EQ 2MG BASE/ML	1	NIMBEX	CISATRACURIUM BESYLATE
002	INJECTABLE;INJECTION	EQ 10MG BASE/ML	1	NIMBEX PRESERVATIVE FREE	CISATRACURIUM BESYLATE
003	INJECTABLE;INJECTION	EQ 2MG BASE/ML	1	NIMBEX PRESERVATIVE FREE	CISATRACURIUM BESYLATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1995-12-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	1998-06-19	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1998-10-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	1999-05-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	1999-05-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-03-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	2000-02-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2000-02-25	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2003-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-10-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	2010-06-02	STANDARD
LABELING; Labeling	SUPPL	19	AP	2010-11-22	901 REQUIRED
LABELING; Labeling	SUPPL	20	AP	2018-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2013-04-01	STANDARD
LABELING; Labeling	SUPPL	26	AP	2018-07-26	STANDARD
LABELING; Labeling	SUPPL	28	AP	2022-10-14	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-10-07	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	17	Null	6
SUPPL	19	Null	6
SUPPL	20	Null	6
SUPPL	23	Null	0
SUPPL	26	Null	7
SUPPL	28	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20551
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIMBEX","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"NIMBEX PRESERVATIVE FREE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"NIMBEX PRESERVATIVE FREE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/26\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/20551Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/20551Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/20551Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2010","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020551s019lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NIMBEX","submission":"CISATRACURIUM BESYLATE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NIMBEX PRESERVATIVE FREE","submission":"CISATRACURIUM BESYLATE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NIMBEX PRESERVATIVE FREE","submission":"CISATRACURIUM BESYLATE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-07-26
        )

)