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 1.

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.

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
2026-08-01 22:54:32	2026-06	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N202293-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 observed states.

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	N202293-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8329648	2026-08-18	U-2213		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8329648	2026-08-18	U-2139		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8329648	2026-08-18	U-2212		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8906851	2026-08-18	U-2139		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8329648*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8906851*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8501698	2027-06-20	U-493	Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8221786	2028-03-21		Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8361972	2028-03-21	U-2139		2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8361972	2028-03-21	U-493		2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8716251	2028-03-21		Drug product	2014-06-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	7851502	2028-08-19		Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8221786*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8361972*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	7851502*PED	2029-02-19		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	7919598	2029-12-16		Drug substance	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8721615	2030-01-18		Drug product, Delist requested	2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8685934	2030-05-26	U-1522		2014-06-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8721615*PED	2030-07-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8685934*PED	2030-11-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8329648	2026-08-18	U-2139		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8329648	2026-08-18	U-2212		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8329648	2026-08-18	U-2213		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8906851	2026-08-18	U-2139		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8329648*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8906851*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8501698	2027-06-20	U-493	Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8221786	2028-03-21		Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8361972	2028-03-21	U-2139		2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8361972	2028-03-21	U-493		2014-02-05	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N202293-001	M-298	2026-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	PED	2026-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	PED	2027-12-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	M-298	2026-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	PED	2026-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	PED	2027-12-12	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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	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