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 44.

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.

Product history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210874-001	QTERNMET XR	2.5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-002	QTERNMET XR	5MG;1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-003	QTERNMET XR	5MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-004	QTERNMET XR	10MG;1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-05-02	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 36 · 1,424 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210874-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	6515117*PED	2026-04-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	8501698	2027-06-20	U-493	Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	8501698*PED	2027-12-20		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	8716251	2028-03-21		Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	8716251*PED	2028-09-21		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	7919598	2029-12-16		Drug substance	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	7919598*PED	2030-06-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	9616028	2030-11-12		Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-001	9616028*PED	2031-05-12		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	6515117*PED	2026-04-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	8501698	2027-06-20	U-493	Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	8501698*PED	2027-12-20		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	8716251	2028-03-21		Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	8716251*PED	2028-09-21		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	7919598	2029-12-16		Drug substance	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	7919598*PED	2030-06-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	9616028	2030-11-12		Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-002	9616028*PED	2031-05-12		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	6515117*PED	2026-04-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	8501698	2027-06-20	U-493	Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	8501698*PED	2027-12-20		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	8716251	2028-03-21		Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	8716251*PED	2028-09-21		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	7919598	2029-12-16		Drug substance	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	7919598*PED	2030-06-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	9616028	2030-11-12		Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-003	9616028*PED	2031-05-12		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	6515117*PED	2026-04-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	8501698	2027-06-20	U-493	Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	8501698*PED	2027-12-20		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	8716251	2028-03-21		Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	8716251*PED	2028-09-21		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	7919598	2029-12-16		Drug substance	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	7919598*PED	2030-06-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	9616028	2030-11-12		Drug product	2019-05-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210874-004	9616028*PED	2031-05-12		Pediatric extension		`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-001	NP	2022-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-002	NP	2022-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-003	NP	2022-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210874-004	NP	2022-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210874-001	NP	2022-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-002	NP	2022-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-003	NP	2022-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210874-004	NP	2022-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210874-001	NP	2022-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-002	NP	2022-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-003	NP	2022-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210874-004	NP	2022-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210874-001	NP	2022-05-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210874-002	NP	2022-05-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210874-003	NP	2022-05-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210874-004	NP	2022-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210874-001	NP	2022-05-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210874-002	NP	2022-05-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210874-003	NP	2022-05-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210874-004	NP	2022-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210874-001	NP	2022-05-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210874-002	NP	2022-05-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210874-003	NP	2022-05-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210874-004	NP	2022-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210874-001	NP	2022-05-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210874-002	NP	2022-05-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210874-003	NP	2022-05-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210874-004	NP	2022-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210874-001	NP	2022-05-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210874-002	NP	2022-05-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210874-003	NP	2022-05-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210874-004	NP	2022-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210874-001	NP	2022-05-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210874-002	NP	2022-05-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210874-003	NP	2022-05-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210874-004	NP	2022-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210874-001	NP	2022-05-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210874-002	NP	2022-05-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210874-003	NP	2022-05-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210874-004	NP	2022-05-02	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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