Application 200678

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	Yes	No
002	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	Yes	Yes
003	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79907	SUPPL	2024-10-15
79897	SUPPL	2024-10-15
79896	SUPPL	2024-10-15
59275	SUPPL	2019-07-08
59274	SUPPL	2019-07-08
59214	SUPPL	2019-07-02
56371	SUPPL	2018-11-08
47497	SUPPL	2017-03-08
47360	SUPPL	2017-02-28
46931	SUPPL	2017-01-24
46930	SUPPL	2017-01-24
46921	SUPPL	2017-01-18
46920	SUPPL	2017-01-18
45270	SUPPL	2016-09-13
9844	SUPPL	2016-04-07
18977	SUPPL	2015-09-04
9845	SUPPL	2015-09-01
23474	ORIG	2013-06-12
18976	SUPPL	2013-06-04
32052	SUPPL	2013-05-28
32051	SUPPL	2012-04-05
32050	SUPPL	2012-03-13
32049	SUPPL	2012-03-13
40042	SUPPL	2012-03-09
40041	SUPPL	2012-03-09
9843	SUPPL	2011-11-21
40043	SUPPL	2011-11-16
44825	ORIG	2011-09-16
22835	ORIG	2011-09-16
32048	ORIG	2010-11-12
18975	ORIG	2010-11-12

Application 200678

Related Records#

Application Products#

NDC Listings For This Application#

Documents#