Application 203414

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KAZANO	ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	EQ 12.5MG BASE;500MG	Yes	No
002	KAZANO	ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	EQ 12.5MG BASE;1GM	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
N203414-001	KAZANO	ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE	EQ 12.5MG BASE;500MG	TABLET / ORAL		RLD	2013-01-25
N203414-002	KAZANO	ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE	EQ 12.5MG BASE;1GM	TABLET / ORAL		RLD, RS	2013-01-25

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203414-001	7807689	2028-06-27	U-1337	Drug substance, Drug product
N203414-001	8900638	2029-05-24		Drug product	2014-12-18
N203414-002	7807689	2028-06-27	U-1337	Drug substance, Drug product
N203414-002	8900638	2029-05-24		Drug product	2014-12-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203414-001	M-300	2026-07-27
N203414-002	M-300	2026-07-27

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203414-001	KAZANO	EQ 12.5MG BASE;500MG	TABLET / ORAL	RLD	2013-01-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203414-002	KAZANO	EQ 12.5MG BASE;1GM	TABLET / ORAL	RLD, RS	2013-01-25	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203414-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203414-001	8900638	2029-05-24		Drug product	2014-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203414-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203414-002	8900638	2029-05-24		Drug product	2014-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-001	8173663	2025-03-15	U-1338			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-001	8288539	2025-06-24		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-001	8900638	2029-05-24		Drug product	2014-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-002	8173663	2025-03-15	U-1338			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-002	8288539	2025-06-24		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-002	8900638	2029-05-24		Drug product	2014-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203414-001	8173663	2025-03-15	U-1338			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-001	8288539	2025-06-24		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-001	8900638	2029-05-24		Drug product	2014-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-002	8173663	2025-03-15	U-1338			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-002	8288539	2025-06-24		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-002	8900638	2029-05-24		Drug product	2014-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-001	8173663	2025-03-15	U-1338			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-001	8288539	2025-06-24		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-001	8900638	2029-05-24		Drug product	2014-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-002	8173663	2025-03-15	U-1338			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-002	8288539	2025-06-24		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-002	8900638	2029-05-24		Drug product	2014-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-001	8173663	2025-03-15	U-1338			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-001	8288539	2025-06-24		Drug substance		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-001	8900638	2029-05-24		Drug product	2014-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-002	8173663	2025-03-15	U-1338			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-002	8288539	2025-06-24		Drug substance		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-002	8900638	2029-05-24		Drug product	2014-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203414-001	8173663	2025-03-15	U-1338			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203414-001	8288539	2025-06-24		Drug substance		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203414-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203414-001	8900638	2029-05-24		Drug product	2014-12-18	`03ed91905a0d…`

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
2026-02-19 14:30 UTC	2026-02	N203414-001	M-300	2026-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203414-002	M-300	2026-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-001	M-300	2026-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203414-002	M-300	2026-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203414-001	M-300	2026-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203414-002	M-300	2026-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-001	M-300	2026-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203414-002	M-300	2026-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-001	M-300	2026-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203414-002	M-300	2026-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203414-001	M-300	2026-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203414-002	M-300	2026-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203414-001	M-300	2026-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203414-002	M-300	2026-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203414-001	M-300	2026-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203414-002	M-300	2026-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203414-001	M-300	2026-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203414-002	M-300	2026-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203414-001	M-300	2026-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203414-002	M-300	2026-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203414-001	M-300	2026-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203414-002	M-300	2026-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203414-001	M-300	2026-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203414-002	M-300	2026-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203414-001	M-300	2026-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203414-002	M-300	2026-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203414-001	M-300	2026-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203414-002	M-300	2026-07-27	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N203414-001	M-177	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203414-002	M-177	2019-04-05	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N203414-001	M-177	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203414-002	M-177	2019-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203414-001	M-177	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203414-002	M-177	2019-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203414-001	M-177	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203414-002	M-177	2019-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203414-001	M-300	2026-07-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203414-002	M-300	2026-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203414-001	M-300	2026-07-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N203414-002	M-300	2026-07-27	`1c564ffb4f44…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KAZANO	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	Takeda Pharmaceuticals America, Inc.	83cb7914-a683-47bb-a713-f2bc6a596bd2	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203414 application number: NDA203414 ndc (product): 64764-335 ndc (product): 64764-337
alogliptin and metformin hydrochloride	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	14d98490-4f8f-4d2f-a4e9-7a3d7a0199ba	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203414 application number: NDA203414 ndc (product): 45802-211 ndc (product): 45802-169
alogliptin and metformin hydrochloride	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	9112d6b9-4771-4194-886d-7db887470bcc	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203414 application number: NDA203414 ndc (product): 50090-5993

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-169	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	Perrigo New York Inc	NDA	Current
45802-169	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	Padagis Israel Pharmaceuticals Ltd	NDA	Current
45802-169	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	Perrigo New York Inc	NDA	Current
45802-169	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	Padagis Israel Pharmaceuticals Ltd	NDA	Current
45802-211	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	Perrigo New York Inc	NDA	Current
45802-211	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	Padagis Israel Pharmaceuticals Ltd	NDA	Current
45802-211	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	Perrigo New York Inc	NDA	Current
45802-211	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	Padagis Israel Pharmaceuticals Ltd	NDA	Current
50090-5993	alogliptin and metformin hydrochloride	alogliptin and metformin hydrochloride	A-S Medication Solutions	NDA	Current
64764-335	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-335	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-335	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-335	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-335	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-335	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-335	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-335	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-337	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-337	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-337	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-337	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-337	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-337	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-337	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-337	KAZANO	alogliptin and metformin hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74946	SUPPL	2023-07-31
74927	SUPPL	2023-07-31
74926	SUPPL	2023-07-31
70518	SUPPL	2022-03-15
70517	SUPPL	2022-03-15
70509	SUPPL	2022-03-14
59257	SUPPL	2019-07-05
59212	SUPPL	2019-07-02
56368	SUPPL	2018-11-08
47253	SUPPL	2017-02-16
46168	SUPPL	2016-12-15
46167	SUPPL	2016-12-15
46148	SUPPL	2016-12-14
46147	SUPPL	2016-12-14
40295	SUPPL	2016-04-07
10210	SUPPL	2016-04-07
19464	SUPPL	2015-09-21
10211	SUPPL	2015-09-01
43430	ORIG	2014-04-18
24434	ORIG	2014-04-18
43966	ORIG	2013-02-05
40294	ORIG	2013-01-30
32420	ORIG	2013-01-30