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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209091-001	QTERN	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	10MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-02-27
N209091-002	QTERN	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	5MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2019-05-02

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209091-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2017-03-22
N209091-001	6515117*PED	2026-04-04		Pediatric extension
N209091-001	8501698	2027-06-20	U-1976	Drug product	2017-03-22
N209091-001	8501698	2027-06-20	U-1977	Drug product	2017-03-22
N209091-001	8501698	2027-06-20	U-493	Drug product	2017-03-22
N209091-001	8501698*PED	2027-12-20		Pediatric extension
N209091-001	8221786	2028-03-21		Drug product	2017-03-22
N209091-001	8361972	2028-03-21	U-1976		2017-03-22
N209091-001	8361972	2028-03-21	U-1977		2017-03-22
N209091-001	8361972	2028-03-21	U-493		2017-03-22
N209091-001	8716251	2028-03-21		Drug product	2017-03-22
N209091-001	8221786*PED	2028-09-21		Pediatric extension
N209091-001	8361972*PED	2028-09-21		Pediatric extension
N209091-001	8716251*PED	2028-09-21		Pediatric extension
N209091-001	7919598	2029-12-16		Drug substance	2017-03-22
N209091-001	7919598*PED	2030-06-16		Pediatric extension
N209091-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24
N209091-002	6515117*PED	2026-04-04		Pediatric extension
N209091-002	8501698	2027-06-20	U-493	Drug product	2019-05-24
N209091-002	8501698*PED	2027-12-20		Pediatric extension
N209091-002	8221786	2028-03-21		Drug product	2019-05-24
N209091-002	8361972	2028-03-21	U-493		2019-05-24
N209091-002	8716251	2028-03-21		Drug product	2019-05-24
N209091-002	8221786*PED	2028-09-21		Pediatric extension
N209091-002	8361972*PED	2028-09-21		Pediatric extension
N209091-002	8716251*PED	2028-09-21		Pediatric extension
N209091-002	7919598	2029-12-16		Drug substance	2019-05-24
N209091-002	7919598*PED	2030-06-16		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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209091-001	QTERN	10MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2017-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	QTERN	5MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2019-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2017-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2017-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2017-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209091-001	QTERN	10MG;EQ 5MG BASE	TABLET / ORAL	RLD, RS	2017-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209091-002	QTERN	5MG;EQ 5MG BASE	TABLET / ORAL	RLD	2019-05-02	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 25 · 972 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209091-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8501698	2027-06-20	U-1976	Drug product	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8501698	2027-06-20	U-1977	Drug product	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8501698	2027-06-20	U-493	Drug product	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8221786	2028-03-21		Drug product	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8361972	2028-03-21	U-1977		2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8361972	2028-03-21	U-1976		2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8361972	2028-03-21	U-493		2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8716251	2028-03-21		Drug product	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8221786*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8361972*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	8716251*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	7919598	2029-12-16		Drug substance	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-001	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	8501698	2027-06-20	U-493	Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	8221786	2028-03-21		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	8361972	2028-03-21	U-493		2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	8716251	2028-03-21		Drug product	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	8221786*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	8361972*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	8716251*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	7919598	2029-12-16		Drug substance	2019-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209091-002	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209091-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	6515117*PED	2026-04-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8501698	2027-06-20	U-1976	Drug product	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8501698	2027-06-20	U-1977	Drug product	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8501698	2027-06-20	U-493	Drug product	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8501698*PED	2027-12-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8221786	2028-03-21		Drug product	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8361972	2028-03-21	U-1977		2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8361972	2028-03-21	U-1976		2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8361972	2028-03-21	U-493		2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8716251	2028-03-21		Drug product	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209091-001	8221786*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 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	N209091-001	I-804	2022-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209091-002	NS	2022-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209091-001	I-804	2022-05-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209091-002	NS	2022-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209091-001	I-804	2022-05-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209091-002	NS	2022-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209091-001	NCE	2019-01-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209091-001	M-175	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209091-001	NC	2020-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209091-001	I-804	2022-05-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209091-002	NS	2022-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209091-001	I-804	2022-05-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209091-002	NS	2022-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209091-001	I-804	2022-05-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209091-002	NS	2022-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209091-001	I-804	2022-05-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209091-002	NS	2022-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209091-001	I-804	2022-05-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209091-002	NS	2022-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209091-001	NC	2020-02-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209091-001	I-804	2022-05-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209091-002	NS	2022-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209091-001	NC	2020-02-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209091-001	I-804	2022-05-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209091-002	NS	2022-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209091-001	NCE	2019-01-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209091-001	M-175	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209091-001	NC	2020-02-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209091-001	I-804	2022-05-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209091-002	NS	2022-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209091-001	NCE	2019-01-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209091-001	M-175	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209091-001	NC	2020-02-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209091-001	I-804	2022-05-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209091-002	NS	2022-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209091-001	NCE	2019-01-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209091-001	M-175	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209091-001	NC	2020-02-27	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N209091-001	I-804	2022-05-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N209091-002	NS	2022-05-02	`3bdfa0b2c4d7…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

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