Application 020616

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
002	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	Yes	No
003	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	Yes
004	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
005	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	Yes	No
006	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	Yes	No
007	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	Yes	Yes
008	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	Yes
009	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
010	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	70MG	Yes	No
011	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	130MG	Yes	No
012	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	150MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66587	SUPPL	2021-03-08
66586	SUPPL	2021-03-08
66505	SUPPL	2021-03-05
60343	SUPPL	2019-10-08
60329	SUPPL	2019-10-08
60328	SUPPL	2019-10-08
55901	SUPPL	2018-10-12
55900	SUPPL	2018-10-12
55661	SUPPL	2018-09-28
55660	SUPPL	2018-09-28
48568	SUPPL	2017-05-30
46383	SUPPL	2016-12-21
46253	SUPPL	2016-12-20
45462	SUPPL	2016-10-04
2888	SUPPL	2016-04-22
2887	SUPPL	2015-07-02
2886	SUPPL	2014-08-20
2885	SUPPL	2014-04-17
34964	SUPPL	2014-04-16
25330	SUPPL	2013-04-17
2884	SUPPL	2013-03-29
34963	SUPPL	2012-07-13
34962	SUPPL	2012-07-12
44453	ORIG	2012-07-11
25329	SUPPL	2012-07-11
20768	SUPPL	2011-02-04
41484	SUPPL	2007-11-19
41483	SUPPL	2007-11-19
25328	SUPPL	2007-05-01
12854	SUPPL	2007-04-25
34960	SUPPL	2007-03-07
25327	SUPPL	2007-03-07
12853	SUPPL	2007-03-07
2882	SUPPL	2007-03-07
34961	SUPPL	2006-11-06
2883	SUPPL	2006-11-06
25326	SUPPL	2005-10-20
12852	SUPPL	2005-09-30