Application 209091

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QTERN	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	TABLET;ORAL	10MG;EQ 5MG BASE	Yes	Yes
002	QTERN	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	TABLET;ORAL	5MG;EQ 5MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-6770	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6770	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6770	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6770	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6770	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6770	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6770	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6770	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6780	QTERN	dapagliflozin and saxagliptin	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75437	SUPPL	2023-09-13
75436	SUPPL	2023-09-13
75416	SUPPL	2023-09-13
72497	SUPPL	2022-10-31
72496	SUPPL	2022-10-31
72325	SUPPL	2022-10-14
70454	SUPPL	2022-03-10
70453	SUPPL	2022-03-10
70418	SUPPL	2022-03-07
61690	SUPPL	2020-01-27
61682	SUPPL	2020-01-27
61681	SUPPL	2020-01-27
59273	SUPPL	2019-07-08
59272	SUPPL	2019-07-08
59215	SUPPL	2019-07-02
58564	SUPPL	2019-05-06
58535	SUPPL	2019-05-03
58534	SUPPL	2019-05-02
56762	SUPPL	2018-12-18
56761	SUPPL	2018-12-18
56148	SUPPL	2018-10-29
55863	ORIG	2018-10-10
52744	ORIG	2018-02-28
47454	ORIG	2017-03-03
47361	ORIG	2017-02-28

Application 209091

Related Records#

Application Products#

NDC Listings For This Application#

Documents#