Application 204353

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INVOKAMET	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	50MG;500MG	Yes	No
002	INVOKAMET	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	50MG;1GM	Yes	No
003	INVOKAMET	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	150MG;500MG	Yes	No
004	INVOKAMET	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	150MG;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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204353-001	INVOKAMET	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	50MG;500MG	TABLET / ORAL	RLD	2014-08-08
N204353-002	INVOKAMET	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	50MG;1GM	TABLET / ORAL	RLD	2014-08-08
N204353-003	INVOKAMET	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	150MG;500MG	TABLET / ORAL	RLD	2014-08-08
N204353-004	INVOKAMET	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08

Orange Book patents#

Current patent rows page 1 of 1 · 44 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204353-001	7943788	2027-07-14		Drug substance, Drug product	2014-09-04
N204353-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04
N204353-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04
N204353-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04
N204353-001	7943788*PED	2028-01-14		Pediatric extension
N204353-001	8513202*PED	2028-06-03		Pediatric extension
N204353-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04
N204353-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04
N204353-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04
N204353-001	7943582*PED	2029-08-26		Pediatric extension
N204353-001	11576894	2030-07-06		Drug product	2023-03-13
N204353-002	7943788	2027-07-14		Drug substance, Drug product	2014-09-04
N204353-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04
N204353-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04
N204353-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04
N204353-002	7943788*PED	2028-01-14		Pediatric extension
N204353-002	8513202*PED	2028-06-03		Pediatric extension
N204353-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04
N204353-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04
N204353-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04
N204353-002	7943582*PED	2029-08-26		Pediatric extension
N204353-002	11576894	2030-07-06		Drug product	2023-03-13
N204353-003	7943788	2027-07-14		Drug substance, Drug product	2014-09-04
N204353-003	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04
N204353-003	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04
N204353-003	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04
N204353-003	7943788*PED	2028-01-14		Pediatric extension
N204353-003	8513202*PED	2028-06-03		Pediatric extension
N204353-003	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04
N204353-003	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04
N204353-003	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04
N204353-003	7943582*PED	2029-08-26		Pediatric extension
N204353-003	11576894	2030-07-06		Drug product	2023-03-13
N204353-004	7943788	2027-07-14		Drug substance, Drug product	2014-09-04
N204353-004	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04
N204353-004	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04
N204353-004	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04
N204353-004	7943788*PED	2028-01-14		Pediatric extension
N204353-004	8513202*PED	2028-06-03		Pediatric extension
N204353-004	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04
N204353-004	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04
N204353-004	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04
N204353-004	7943582*PED	2029-08-26		Pediatric extension
N204353-004	11576894	2030-07-06		Drug product	2023-03-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204353-001	NPP	2027-12-18
N204353-001	PED	2028-06-18
N204353-002	NPP	2027-12-18
N204353-002	PED	2028-06-18
N204353-003	NPP	2027-12-18
N204353-003	PED	2028-06-18
N204353-004	NPP	2027-12-18
N204353-004	PED	2028-06-18

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 5 · 164 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	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204353-001	INVOKAMET	50MG;500MG	TABLET / ORAL	RLD	2014-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204353-002	INVOKAMET	50MG;1GM	TABLET / ORAL	RLD	2014-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204353-003	INVOKAMET	150MG;500MG	TABLET / ORAL	RLD	2014-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204353-004	INVOKAMET	150MG;1GM	TABLET / ORAL	RLD, RS	2014-08-08	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,904 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	N204353-001	7943788	2027-07-14		Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	11576894	2030-07-06		Drug product	2023-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943788	2027-07-14		Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	11576894	2030-07-06		Drug product	2023-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943788	2027-07-14		Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943582	2029-02-26	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943582	2029-02-26	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	11576894	2030-07-06		Drug product	2023-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	7943788	2027-07-14		Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	8513202	2027-12-03	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	8513202	2027-12-03	U-2441	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	8513202	2027-12-03	U-2632	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	7943582	2029-02-26	U-493	Drug substance, Drug product	2014-09-04	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 124 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	N204353-001	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-001	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-002	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-003	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204353-004	PED	2028-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-001	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-001	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-002	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-002	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-003	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-003	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-004	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204353-004	PED	2028-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204353-001	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-001	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-002	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-002	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-003	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-003	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-004	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204353-004	PED	2028-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-001	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-001	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-002	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-002	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-003	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-003	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-004	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204353-004	PED	2028-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-001	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-001	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-002	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-002	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-003	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-003	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-004	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204353-004	PED	2028-06-18	`b8a1b40f171c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INVOKAMET	CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Janssen Pharmaceuticals, Inc.	6868666b-c25e-40d1-9d1f-306bbe9390c1	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204353 application number: NDA204353 ndc (product): 50458-540 ndc (product): 50458-542 ndc (product): 50458-541 ndc (product): 50458-543

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-540	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-540	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-540	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-540	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-540	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-540	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-541	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-541	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-541	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-541	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-541	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-541	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-542	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-542	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-542	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-542	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-542	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-542	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-543	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-543	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-543	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-543	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-543	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-543	INVOKAMET	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
63629-8260	INVOKAMET	canagliflozin and metformin hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-8260	INVOKAMET	canagliflozin and metformin hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80652	SUPPL	2024-12-19
80633	SUPPL	2024-12-19
80632	SUPPL	2024-12-19
79482	SUPPL	2024-08-26
79472	SUPPL	2024-08-26
77271	SUPPL	2024-01-23
77261	SUPPL	2024-01-22
74707	SUPPL	2023-07-07
74699	SUPPL	2023-07-06
72351	SUPPL	2022-10-17
72345	SUPPL	2022-10-17
72332	SUPPL	2022-10-14
64318	SUPPL	2020-08-19
64317	SUPPL	2020-08-19
64306	SUPPL	2020-08-19
61709	SUPPL	2020-01-28
61708	SUPPL	2020-01-28
61701	SUPPL	2020-01-28
61693	SUPPL	2020-01-27
61649	SUPPL	2020-01-27
56211	SUPPL	2018-10-31
56205	SUPPL	2018-10-31
56197	SUPPL	2018-10-30
56173	SUPPL	2018-10-30
49482	SUPPL	2017-08-21
49357	SUPPL	2017-08-14
49117	SUPPL	2017-07-28
49062	SUPPL	2017-07-25
47086	SUPPL	2017-02-01
47083	SUPPL	2017-02-01
45092	SUPPL	2016-08-22
45050	SUPPL	2016-08-17
32544	SUPPL	2016-05-24
10328	SUPPL	2016-05-24
40378	SUPPL	2016-05-23
40376	SUPPL	2016-05-23
19549	SUPPL	2016-03-30
10329	SUPPL	2016-03-30
40377	SUPPL	2015-12-08
10330	SUPPL	2015-12-08
32543	SUPPL	2015-09-14
19548	SUPPL	2015-09-11
40375	SUPPL	2015-03-20
10327	SUPPL	2015-03-04
44899	ORIG	2014-09-03
22952	ORIG	2014-09-03
19547	ORIG	2014-08-12
10326	ORIG	2014-08-11