Application 211582

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211582-001	DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB		2026-04-06
A211582-002	DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB		2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211582-001	AB
A211582-002	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2026-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2026-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2026-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2026-04-06	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2022-02-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2022-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2022-02-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2022-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2022-02-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2022-02-22	`4b0b4de00fa7…`
2024-02-18 07:12 UTC	2024-02	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2022-02-22	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2022-02-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2026-04-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2026-04-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211582-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211582-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211582-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211582-002	AB	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211582-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211582-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211582-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211582-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211582-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211582-002	AB	1	`4b0b4de00fa7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211582-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211582-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211582-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211582-002	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dapagliflozin	DAPAGLIFLOZIN	Zydus Pharmaceuticals USA Inc.	17586ec6-0104-4b08-ad87-12a837568d6c	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211582 application number: ANDA211582
Dapagliflozin	DAPAGLIFLOZIN	Zydus Lifesciences Limited	db668c5c-2d49-41c8-8ffd-c2b2652b621a	2026-04-06		Exact identifier application applno (ANDA): 211582 application number: ANDA211582

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65508	ORIG	2020-12-07