Application 210874

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2.5MG;1GM;EQ 2.5MG BASE	Yes	No
002	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM;EQ 2.5MG BASE	Yes	No
003	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM;EQ 5MG BASE	Yes	No
004	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM;EQ 5MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210874-001	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02
N210874-002	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02
N210874-003	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02
N210874-004	QTERNMET XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02

Orange Book patents#

Current patent rows page 1 of 1 · 40 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210874-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N210874-001	6515117*PED	2026-04-04		Pediatric extension
N210874-001	8501698	2027-06-20	U-493	Drug product	2019-05-24
N210874-001	8501698*PED	2027-12-20		Pediatric extension
N210874-001	8716251	2028-03-21		Drug product	2019-05-24
N210874-001	8716251*PED	2028-09-21		Pediatric extension
N210874-001	7919598	2029-12-16		Drug substance	2019-05-24
N210874-001	7919598*PED	2030-06-16		Pediatric extension
N210874-001	9616028	2030-11-12		Drug product	2019-05-24
N210874-001	9616028*PED	2031-05-12		Pediatric extension
N210874-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N210874-002	6515117*PED	2026-04-04		Pediatric extension
N210874-002	8501698	2027-06-20	U-493	Drug product	2019-05-24
N210874-002	8501698*PED	2027-12-20		Pediatric extension
N210874-002	8716251	2028-03-21		Drug product	2019-05-24
N210874-002	8716251*PED	2028-09-21		Pediatric extension
N210874-002	7919598	2029-12-16		Drug substance	2019-05-24
N210874-002	7919598*PED	2030-06-16		Pediatric extension
N210874-002	9616028	2030-11-12		Drug product	2019-05-24
N210874-002	9616028*PED	2031-05-12		Pediatric extension
N210874-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N210874-003	6515117*PED	2026-04-04		Pediatric extension
N210874-003	8501698	2027-06-20	U-493	Drug product	2019-05-24
N210874-003	8501698*PED	2027-12-20		Pediatric extension
N210874-003	8716251	2028-03-21		Drug product	2019-05-24
N210874-003	8716251*PED	2028-09-21		Pediatric extension
N210874-003	7919598	2029-12-16		Drug substance	2019-05-24
N210874-003	7919598*PED	2030-06-16		Pediatric extension
N210874-003	9616028	2030-11-12		Drug product	2019-05-24
N210874-003	9616028*PED	2031-05-12		Pediatric extension
N210874-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N210874-004	6515117*PED	2026-04-04		Pediatric extension
N210874-004	8501698	2027-06-20	U-493	Drug product	2019-05-24
N210874-004	8501698*PED	2027-12-20		Pediatric extension
N210874-004	8716251	2028-03-21		Drug product	2019-05-24
N210874-004	8716251*PED	2028-09-21		Pediatric extension
N210874-004	7919598	2029-12-16		Drug substance	2019-05-24
N210874-004	7919598*PED	2030-06-16		Pediatric extension
N210874-004	9616028	2030-11-12		Drug product	2019-05-24
N210874-004	9616028*PED	2031-05-12		Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N210874-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	8501698	2027-06-20	U-493	Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	8716251	2028-03-21		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	7919598	2029-12-16		Drug substance	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	9616028	2030-11-12		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-001	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	8501698	2027-06-20	U-493	Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	8716251	2028-03-21		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	7919598	2029-12-16		Drug substance	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	9616028	2030-11-12		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-002	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	8501698	2027-06-20	U-493	Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	8716251	2028-03-21		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	7919598	2029-12-16		Drug substance	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	9616028	2030-11-12		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-003	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	8501698	2027-06-20	U-493	Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	8716251	2028-03-21		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	7919598	2029-12-16		Drug substance	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	9616028	2030-11-12		Drug product	2019-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210874-004	9616028*PED	2031-05-12		Pediatric extension		`a50c72e98297…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-6925	QTERNMET	dapagliflozin saxagliptin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6950	QTERNMET	dapagliflozin saxagliptin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6975	QTERNMET	dapagliflozin saxagliptin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6990	QTERNMET	dapagliflozin saxagliptin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61691	SUPPL	2020-01-27
61687	SUPPL	2020-01-27
61685	SUPPL	2020-01-27
61651	ORIG	2020-01-27
59271	SUPPL	2019-07-08
59270	SUPPL	2019-07-08
59216	SUPPL	2019-07-02
58559	ORIG	2019-05-03
58538	ORIG	2019-05-03
58537	ORIG	2019-05-03