Application 022271

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NESINA	ALOGLIPTIN BENZOATE	TABLET;ORAL	EQ 6.25MG BASE	Yes	No
002	NESINA	ALOGLIPTIN BENZOATE	TABLET;ORAL	EQ 12.5MG BASE	Yes	No
003	NESINA	ALOGLIPTIN BENZOATE	TABLET;ORAL	EQ 25MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022271-001	NESINA	ALOGLIPTIN BENZOATE	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25
N022271-002	NESINA	ALOGLIPTIN BENZOATE	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25
N022271-003	NESINA	ALOGLIPTIN BENZOATE	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product
N022271-001	8697125	2029-06-16		Drug product	2014-05-27
N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product
N022271-002	8697125	2029-06-16		Drug product	2014-05-27
N022271-003	7807689	2028-06-27	U-1337	Drug substance, Drug product
N022271-003	8697125	2029-06-16		Drug product	2014-05-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022271-001	M-300	2026-07-27
N022271-002	M-300	2026-07-27
N022271-003	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 4 · 123 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	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 516 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	N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-001	8697125	2029-06-16		Drug product	2014-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-002	8697125	2029-06-16		Drug product	2014-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-003	7807689	2028-06-27	U-1337	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-003	8697125	2029-06-16		Drug product	2014-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	8288539	2025-03-15		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	8173663	2025-12-02	U-1338		2017-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	8697125	2029-06-16		Drug product	2014-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	8288539	2025-03-15		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	8173663	2025-12-02	U-1338		2017-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	8697125	2029-06-16		Drug product	2014-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	8288539	2025-03-15		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	8173663	2025-12-02	U-1338		2017-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	7807689	2028-06-27	U-1337	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	8697125	2029-06-16		Drug product	2014-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022271-001	8288539	2025-03-15		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-001	8173663	2025-12-02	U-1338		2017-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-001	8697125	2029-06-16		Drug product	2014-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	8288539	2025-03-15		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	8173663	2025-12-02	U-1338		2017-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	8697125	2029-06-16		Drug product	2014-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	8288539	2025-03-15		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	8173663	2025-12-02	U-1338		2017-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	7807689	2028-06-27	U-1337	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	8697125	2029-06-16		Drug product	2014-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	8288539	2025-03-15		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	8173663	2025-12-02	U-1338		2017-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	8697125	2029-06-16		Drug product	2014-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	8288539	2025-03-15		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	8173663	2025-12-02	U-1338		2017-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	8697125	2029-06-16		Drug product	2014-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-003	8288539	2025-03-15		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-003	8173663	2025-12-02	U-1338		2017-01-19	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 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	N022271-001	M-300	2026-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-002	M-300	2026-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-003	M-300	2026-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	M-300	2026-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	M-300	2026-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	M-300	2026-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022271-001	M-300	2026-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	M-300	2026-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	M-300	2026-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	M-300	2026-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	M-300	2026-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-003	M-300	2026-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-001	M-300	2026-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-002	M-300	2026-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-003	M-300	2026-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-001	M-300	2026-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-002	M-300	2026-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-003	M-300	2026-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-001	M-300	2026-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-002	M-300	2026-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-003	M-300	2026-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-001	M-300	2026-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-002	M-300	2026-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-003	M-300	2026-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-001	M-300	2026-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-002	M-300	2026-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-003	M-300	2026-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022271-001	M-300	2026-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022271-002	M-300	2026-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022271-003	M-300	2026-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-001	M-300	2026-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-002	M-300	2026-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-003	M-300	2026-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-001	M-300	2026-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-002	M-300	2026-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-003	M-300	2026-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-001	M-300	2026-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-002	M-300	2026-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-003	M-300	2026-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022271-001	M-300	2026-07-27	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alogliptin	ALOGLIPTIN	Padagis Israel Pharmaceuticals Ltd	b25f155a-1259-47c2-aa3b-7c1356e4c7f6	2025-04-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271 ndc (product): 45802-150 ndc (product): 45802-087 ndc (product): 45802-103
Nesina	ALOGLIPTIN	Takeda Pharmaceuticals America, Inc.	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271 ndc (product): 64764-250 ndc (product): 64764-125 ndc (product): 64764-625
Alogliptin	ALOGLIPTIN	Bryant Ranch Prepack	f2ad6d21-8060-42c7-8b3f-ad80085dc022	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271
Alogliptin	ALOGLIPTIN	A-S Medication Solutions	38d30e4f-4212-4f7a-96b5-74b277b56cba	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271 ndc (product): 50090-5574
Alogliptin	ALOGLIPTIN	Aphena Pharma Solutions - Tennessee, LLC	4b007011-547a-498e-b8f6-34ea4ea00eb4	2023-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271 ndc (product): 71610-300
Alogliptin	ALOGLIPTIN	Aphena Pharma Solutions - Tennessee, LLC	a05d6d17-79f9-4788-a4d5-467bca1a2d91	2022-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271 ndc (product): 71610-661

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-087	Alogliptin	Alogliptin	Padagis Israel Pharmaceuticals Ltd	NDA AUTHORIZED GENERIC	Current
45802-087	Alogliptin	Alogliptin	Padagis Israel Pharmaceuticals Ltd	NDA AUTHORIZED GENERIC	Current
45802-087	Alogliptin	Alogliptin	Perrigo New York Inc	NDA AUTHORIZED GENERIC	Current
45802-087	Alogliptin	Alogliptin	Perrigo New York Inc	NDA AUTHORIZED GENERIC	Current
45802-103	Alogliptin	Alogliptin	Padagis Israel Pharmaceuticals Ltd	NDA AUTHORIZED GENERIC	Current
45802-103	Alogliptin	Alogliptin	Padagis Israel Pharmaceuticals Ltd	NDA AUTHORIZED GENERIC	Current
45802-103	Alogliptin	Alogliptin	Perrigo New York Inc	NDA AUTHORIZED GENERIC	Current
45802-103	Alogliptin	Alogliptin	Perrigo New York Inc	NDA AUTHORIZED GENERIC	Current
45802-150	Alogliptin	Alogliptin	Padagis Israel Pharmaceuticals Ltd	NDA AUTHORIZED GENERIC	Current
45802-150	Alogliptin	Alogliptin	Padagis Israel Pharmaceuticals Ltd	NDA AUTHORIZED GENERIC	Current
45802-150	Alogliptin	Alogliptin	Perrigo New York Inc	NDA AUTHORIZED GENERIC	Current
45802-150	Alogliptin	Alogliptin	Perrigo New York Inc	NDA AUTHORIZED GENERIC	Current
50090-5574	Alogliptin	Alogliptin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5574	Alogliptin	Alogliptin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
64764-125	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-125	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-125	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-125	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-125	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-125	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-125	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-125	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-250	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-250	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-250	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-250	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-250	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-250	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-250	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-250	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-625	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-625	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-625	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-625	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-625	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-625	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-625	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-625	Nesina	alogliptin	Takeda Pharmaceuticals America, Inc.	NDA	Current
71610-300	Alogliptin	Alogliptin	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
71610-661	Alogliptin	Alogliptin	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
71610-661	Alogliptin	Alogliptin	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74945	SUPPL	2023-07-31
74929	SUPPL	2023-07-31
74928	SUPPL	2023-07-31
70531	SUPPL	2022-03-16
70514	SUPPL	2022-03-15
70507	SUPPL	2022-03-14
59254	SUPPL	2019-07-05
59253	SUPPL	2019-07-05
59210	SUPPL	2019-07-02
46169	SUPPL	2016-12-15
46146	SUPPL	2016-12-14
17175	SUPPL	2016-06-01
7144	SUPPL	2016-05-31
38475	SUPPL	2016-04-07
7142	SUPPL	2016-04-07
38476	SUPPL	2015-09-21
7143	SUPPL	2015-09-01
44722	ORIG	2013-03-25
21974	ORIG	2013-03-25
43846	ORIG	2013-02-05
38474	ORIG	2013-01-30
7141	ORIG	2013-01-30