Application 202293

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FARXIGA	DAPAGLIFLOZIN	TABLET;ORAL	5MG	Yes	No
002	FARXIGA	DAPAGLIFLOZIN	TABLET;ORAL	10MG	Yes	Yes

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
N202293-001	FARXIGA	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	RLD	2014-01-08
N202293-002	FARXIGA	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N202293-001	AB
N202293-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 64 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202293-001	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05
N202293-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05
N202293-001	6515117*PED	2026-04-04		Pediatric extension
N202293-001	8329648	2026-08-18	U-2139		2017-11-15
N202293-001	8329648	2026-08-18	U-2212		2017-11-15
N202293-001	8329648	2026-08-18	U-2213		2017-11-15
N202293-001	8906851	2026-08-18	U-2139		2017-11-15
N202293-001	8329648*PED	2027-02-18		Pediatric extension
N202293-001	8906851*PED	2027-02-18		Pediatric extension
N202293-001	8501698	2027-06-20	U-493	Drug product	2014-02-05
N202293-001	8501698*PED	2027-12-20		Pediatric extension
N202293-001	8221786	2028-03-21		Drug product	2014-02-05
N202293-001	8361972	2028-03-21	U-2139		2014-02-05
N202293-001	8361972	2028-03-21	U-493		2014-02-05
N202293-001	8716251	2028-03-21		Drug product	2014-06-02
N202293-001	7851502	2028-08-19		Drug product	2014-02-05
N202293-001	8221786*PED	2028-09-21		Pediatric extension
N202293-001	8361972*PED	2028-09-21		Pediatric extension
N202293-001	8716251*PED	2028-09-21		Pediatric extension
N202293-001	7851502*PED	2029-02-19		Pediatric extension
N202293-001	7919598	2029-12-16		Drug substance	2014-02-05
N202293-001	8721615	2030-01-18		Drug product, Delist requested	2017-11-15
N202293-001	8685934	2030-05-26	U-1522		2014-06-25
N202293-001	7919598*PED	2030-06-16		Pediatric extension
N202293-001	8721615*PED	2030-07-18		Pediatric extension
N202293-001	8685934*PED	2030-11-26		Pediatric extension
N202293-002	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05
N202293-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05
N202293-002	6515117*PED	2026-04-04		Pediatric extension
N202293-002	8329648	2026-08-18	U-2139		2017-11-15
N202293-002	8329648	2026-08-18	U-2212		2017-11-15
N202293-002	8329648	2026-08-18	U-2213		2017-11-15
N202293-002	8906851	2026-08-18	U-2139		2017-11-15
N202293-002	8329648*PED	2027-02-18		Pediatric extension
N202293-002	8906851*PED	2027-02-18		Pediatric extension
N202293-002	8501698	2027-06-20	U-493	Drug product	2014-02-05
N202293-002	8501698*PED	2027-12-20		Pediatric extension
N202293-002	8221786	2028-03-21		Drug product	2014-02-05
N202293-002	8361972	2028-03-21	U-2139		2014-02-05
N202293-002	8361972	2028-03-21	U-493		2014-02-05
N202293-002	8716251	2028-03-21		Drug product	2014-06-02
N202293-002	7851502	2028-08-19		Drug product	2014-02-05
N202293-002	8221786*PED	2028-09-21		Pediatric extension
N202293-002	8361972*PED	2028-09-21		Pediatric extension
N202293-002	8716251*PED	2028-09-21		Pediatric extension
N202293-002	7851502*PED	2029-02-19		Pediatric extension
N202293-002	7919598	2029-12-16		Drug substance	2014-02-05
N202293-002	8721615	2030-01-18		Drug product, Delist requested	2017-11-15
N202293-002	8685934	2030-05-26	U-1522		2014-06-25
N202293-002	7919598*PED	2030-06-16		Pediatric extension
N202293-002	8721615*PED	2030-07-18		Pediatric extension
N202293-002	8685934*PED	2030-11-26		Pediatric extension
N202293-002	11826376	2039-07-18	U-3766		2023-12-19
N202293-002	12472194	2039-07-18	U-4346		2025-12-11
N202293-002	11826376*PED	2040-01-18		Pediatric extension
N202293-002	12472194*PED	2040-01-18		Pediatric extension
N202293-002	10973836	2040-03-09	U-3127		2021-04-21
N202293-002	11903955	2040-03-09	U-3825		2024-03-13
N202293-002	10973836*PED	2040-09-09		Pediatric extension
N202293-002	11903955*PED	2040-09-09		Pediatric extension
N202293-002	12213988	2041-04-01	U-4140		2025-03-04
N202293-002	12409186	2041-04-01	U-4140		2025-09-29
N202293-002	12213988*PED	2041-10-01		Pediatric extension
N202293-002	12409186*PED	2041-10-01		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202293-001	M-298	2026-05-08
N202293-001	PED	2026-11-08
N202293-001	NPP	2027-06-12
N202293-001	PED	2027-12-12
N202293-002	M-298	2026-05-08
N202293-002	PED	2026-11-08
N202293-002	NPP	2027-06-12
N202293-002	PED	2027-12-12

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N202293-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	AB	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202293-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202293-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202293-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202293-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202293-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202293-002	AB	1	`4b0b4de00fa7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202293-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202293-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202293-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202293-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 55 · 2,162 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	N202293-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8329648	2026-08-18	U-2213		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8329648	2026-08-18	U-2139		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8329648	2026-08-18	U-2212		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8906851	2026-08-18	U-2139		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8329648*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8906851*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8501698	2027-06-20	U-493	Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8221786	2028-03-21		Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8361972	2028-03-21	U-2139		2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8361972	2028-03-21	U-493		2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8716251	2028-03-21		Drug product	2014-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	7851502	2028-08-19		Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8221786*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8361972*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8716251*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	7851502*PED	2029-02-19		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	7919598	2029-12-16		Drug substance	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8721615	2030-01-18		Drug product, Delist requested	2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8685934	2030-05-26	U-1522		2014-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8721615*PED	2030-07-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8685934*PED	2030-11-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8329648	2026-08-18	U-2139		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8329648	2026-08-18	U-2212		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8329648	2026-08-18	U-2213		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8906851	2026-08-18	U-2139		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8329648*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8906851*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8501698	2027-06-20	U-493	Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8221786	2028-03-21		Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8361972	2028-03-21	U-2139		2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8361972	2028-03-21	U-493		2014-02-05	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 306 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N202293-001	M-298	2026-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	PED	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	PED	2027-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	M-298	2026-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	PED	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	PED	2027-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202293-001	M-298	2026-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-001	PED	2026-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-001	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-001	PED	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	M-298	2026-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	PED	2026-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	PED	2027-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	M-298	2026-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	PED	2026-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	PED	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	M-298	2026-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	PED	2026-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	PED	2027-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202293-001	M-298	2026-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-001	PED	2026-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-001	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-001	PED	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	M-298	2026-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	PED	2026-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	PED	2027-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	M-298	2026-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	PED	2026-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	NPP	2027-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	PED	2027-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	M-298	2026-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	PED	2026-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	NPP	2027-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	PED	2027-12-12	`fd3edfee7708…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	01f90c94-71cb-4a1f-81ff-8004b850529b	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293 ndc (product): 50090-3482 ndc (product): 50090-3481
DAPAGLIFLOZIN	DAPAGLIFLOZIN	Prasco Laboratories	3aba33aa-f8c6-4b10-85c8-dfa14578d07c	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	72ad22ae-efe6-4cd6-a302-98aaee423d69	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293 ndc (product): 0310-6210 ndc (product): 0310-6205
FARXIGA	DAPAGLIFLOZIN	REMEDYREPACK INC.	ef9e9c8c-5460-4193-952a-0c249dd071bd	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
DAPAGLIFLOZIN	DAPAGLIFLOZIN	Bryant Ranch Prepack	979205ee-b0b8-4483-ae61-f283f750bb7f	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
DAPAGLIFLOZIN	DAPAGLIFLOZIN	A-S Medication Solutions	82cdd5ad-df2b-4bdd-a3a6-a059040100b4	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
DAPAGLIFLOZIN	DAPAGLIFLOZIN	A-S Medication Solutions	87521963-0d2a-4a2a-89c6-d50e8582419e	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6205	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6210	FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	NDA	Current
50090-3481	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3481	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3481	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3481	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3481	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3481	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3482	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3482	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3482	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
50090-3482	FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health 107, LLC	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health 107, LLC	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health 107, LLC	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6932	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health 107, LLC	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health 107, LLC	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health 107, LLC	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current
55154-6933	FARXIGA	DAPAGLIFLOZIN	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78794	SUPPL	2024-06-13
78793	SUPPL	2024-06-13
78789	SUPPL	2024-06-13
75424	SUPPL	2023-09-13
75412	SUPPL	2023-09-13
74969	SUPPL	2023-08-01
74198	SUPPL	2023-05-09
74194	SUPPL	2023-05-09
73119	SUPPL	2023-01-09
73118	SUPPL	2023-01-09
73098	SUPPL	2023-01-05
72370	SUPPL	2022-10-17
72369	SUPPL	2022-10-17
72327	SUPPL	2022-10-14
69650	SUPPL	2021-12-20
68890	SUPPL	2021-10-05
68761	SUPPL	2021-09-24
67391	SUPPL	2021-05-04
67322	SUPPL	2021-05-03
67321	SUPPL	2021-05-03
62832	SUPPL	2020-05-06
62829	SUPPL	2020-05-06
62828	SUPPL	2020-05-06
61769	SUPPL	2020-04-10
61774	SUPPL	2020-02-04
61770	SUPPL	2020-02-04
61688	SUPPL	2020-01-27
61680	SUPPL	2020-01-27
61679	SUPPL	2020-01-27
60616	SUPPL	2019-10-22
60603	SUPPL	2019-10-21
60602	SUPPL	2019-10-21
57820	SUPPL	2019-02-27
57800	SUPPL	2019-02-25
56193	SUPPL	2018-10-30
56146	SUPPL	2018-10-29
50159	SUPPL	2017-10-24
50134	SUPPL	2017-10-23
47460	SUPPL	2017-03-03
47395	SUPPL	2017-03-02
45091	SUPPL	2016-08-22
45049	SUPPL	2016-08-17
40164	SUPPL	2016-06-17
10018	SUPPL	2016-06-16
40163	SUPPL	2015-12-08
32229	SUPPL	2015-12-08
19314	SUPPL	2015-03-17
10016	SUPPL	2015-03-12
19315	SUPPL	2014-08-12
10017	SUPPL	2014-08-11
68891	ORIG	2014-02-11
24414	ORIG	2014-02-11
22884	ORIG	2014-02-11
40162	ORIG	2014-01-10
10015	ORIG	2014-01-10