Application 212198

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	UNKNOWN	UNKNOWN	No	No
002	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG; 1G	No	No
003	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	12.5MG; 500MG	No	No
004	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	12.5MG; 1GM	No	No

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	Approval date
A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07
A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07
A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07
A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07

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 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212198-001	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	2022-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212198-002	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET / ORAL	2022-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212198-003	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;500MG	TABLET / ORAL	2022-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212198-004	EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET / ORAL	2022-07-07	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212198-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212198-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212198-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212198-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212198-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212198-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212198-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212198-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212198-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212198-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212198-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212198-004	AB	1	`e64feba35796…`

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
63104	ORIG	2020-05-19