Application 021748

Type: NDA
Sponsor: SANTARUS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLUMETZA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	Yes	No
002	GLUMETZA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13913-002	Glumetza	metformin hydrochloride	Depomed, Inc.	NDA	Current
13913-003	Glumetza	metformin hydrochloride	Depomed, Inc.	NDA	Current
68012-002	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-002	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-002	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-002	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-003	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-003	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-003	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-003	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-004	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-004	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-004	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-004	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68682-017	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-018	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-018	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-018	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-021	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-021	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-021	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56459	SUPPL	2018-11-15
56400	SUPPL	2018-11-09
47927	SUPPL	2017-04-11
6111	SUPPL	2011-04-19
37577	SUPPL	2011-04-15
28515	SUPPL	2010-03-03
28514	SUPPL	2009-06-23
37576	SUPPL	2009-06-22
37575	SUPPL	2006-11-06
6110	SUPPL	2006-11-06
21802	ORIG	2006-09-07
28513	ORIG	2005-06-07
16302	ORIG	2005-06-07

Application 021748

Related Records#

Application Products#

NDC Listings For This Application#

Documents#